Trial Outcomes & Findings for Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer (NCT NCT00430183)
NCT ID: NCT00430183
Last Updated: 2023-02-09
Results Overview
Proportion of participants surviving 3 years from randomization without biochemical progression or death. bPFS was defined as the time from randomization to the date of the first documented biochemical progression or death. Progression will be defined as having experienced either of the following: a serum PSA level \> 0.2 ng/mL that increases on 2 consecutive occasions each of which is at least 3 months apart or death occurs. The time of biochemical failure is measured from the date of randomization to the date of the first PSA level \> 0.2 ng/mL.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
788 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2023-02-09
Participant Flow
Participant milestones
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
Patients receive six cycles of 75 mg/m\^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery(surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
|---|---|---|
|
Overall Study
STARTED
|
391
|
397
|
|
Overall Study
COMPLETED
|
391
|
397
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
n=391 Participants
Patients receive six cycles of 75 mg/m\^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.\> \> Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. \>
\> Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
n=397 Participants
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
Total
n=788 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
391 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
788 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
330 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
667 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Clinical stage by digital rectal examination (Primary Tumor (T) Stage)
T1
|
102 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Clinical stage by digital rectal examination (Primary Tumor (T) Stage)
T2
|
219 Participants
n=5 Participants
|
204 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Clinical stage by digital rectal examination (Primary Tumor (T) Stage)
T3a
|
70 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsProportion of participants surviving 3 years from randomization without biochemical progression or death. bPFS was defined as the time from randomization to the date of the first documented biochemical progression or death. Progression will be defined as having experienced either of the following: a serum PSA level \> 0.2 ng/mL that increases on 2 consecutive occasions each of which is at least 3 months apart or death occurs. The time of biochemical failure is measured from the date of randomization to the date of the first PSA level \> 0.2 ng/mL.
Outcome measures
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
n=391 Participants
Patients receive six cycles of 75 mg/m\^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.\> \> Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. \>
\> Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
n=397 Participants
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
|---|---|---|
|
Proportion of Biochemical Progression-Free Survival (bPFS Proportion) at 3 Years
|
0.89 proportion of patients
Interval 0.87 to 0.91
|
0.84 proportion of patients
Interval 0.78 to 0.9
|
SECONDARY outcome
Timeframe: 5 yearsProportion of participants surviving 5 years from randomization without biochemical progression or death.
Outcome measures
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
n=391 Participants
Patients receive six cycles of 75 mg/m\^2 docetaxel administered every 3 weeks combined with 18-24 weeks of androgen deprivation therapy. During each cycle of chemotherapy, all patients should undergo premedication with dexamethasone 8 mg orally prior to docetaxel. Dexamethasone may also be given intravenously according to institutional guidelines.\> \> Patients will also receive androgen deprivation for 18-24 weeks of an LHRH agonist (eg, leuprolide acetate, goserelin acetate). Additional premedication and antiemetics may be given at the physician's discretion and as defined by the protocol. \>
\> Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
n=397 Participants
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
|---|---|---|
|
5-year bPFS Rate
|
0.81 Proportion of participants
|
0.74 Proportion of participants
|
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 years post-randomizationOutcome measures
Outcome data not reported
Adverse Events
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
Serious events: 31 serious events
Other events: 361 other events
Deaths: 39 deaths
Arm B: Surgical Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
n=391 participants at risk
Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Eye disorders
Watering eyes
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Colitis
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
7/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Mucositis oral (funct/sympt)
|
1.5%
6/391 • Number of events 6 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
12/391 • Number of events 14 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
4/391 • Number of events 4 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Edema limbs
|
1.0%
4/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Fatigue
|
5.1%
20/391 • Number of events 26 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Localized edema
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Pain
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Immune system disorders
Hypersensitivity
|
0.77%
3/391 • Number of events 4 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Pneumonia(gr 0/1/2 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Sinusitis(unknown ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Blood bilirubin increased
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Leukocyte count decreased
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Neutrophil count decreased
|
2.6%
10/391 • Number of events 11 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
6/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
7/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Dysgeusia
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Headache
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
8/391 • Number of events 9 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Psychiatric disorders
Insomnia
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.0%
8/391 • Number of events 9 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Hot flashes
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Hypertension
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Hypotension
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Thrombosis
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
Other adverse events
| Measure |
Arm A: Docetaxel + LHRH Agonist + Surgical Intervention
n=391 participants at risk
Patients will undergo standard surgical intervention. The surgical procedures will be performed within 60 days of the completion of neoadjuvant therapy. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. It must be initiated within 6 months of the date of surgery.
|
Arm B: Surgical Intervention
All patients undergo standard surgical intervention. The surgical procedures will be performed within 60 days of randomization. Patients are allowed to receive adjuvant external beam radiation at the discretion of the treating physician and as defined per the protocol. Adjuvant radiation must be initiated within 6 months of the date of surgery (surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy).
|
|---|---|---|
|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
1.3%
5/391 • Number of events 6 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Tooth infection(gr 3/4 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Injury, poisoning and procedural complications
Intraop. inj. - NERVE: facial sens-taste
|
0.51%
2/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.51%
2/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
4/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Alkaline phosphatase increased
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
5/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Blood bilirubin increased
|
2.6%
10/391 • Number of events 13 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.6%
14/391 • Number of events 14 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Eye disorders
Retinal detachment
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Eye disorders
Vision blurred
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Diarrhea
|
32.7%
128/391 • Number of events 255 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Mucositis oral (funct/sympt)
|
26.1%
102/391 • Number of events 221 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Nausea
|
40.4%
158/391 • Number of events 380 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Rectal pain
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Stomach pain
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
42/391 • Number of events 67 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Chills
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Edema limbs
|
29.7%
116/391 • Number of events 249 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Fatigue
|
82.4%
322/391 • Number of events 1340 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Sinusitis(gr 0/1/2 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Fever
|
0.51%
2/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Localized edema
|
1.5%
6/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
General disorders
Pain
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Immune system disorders
Hypersensitivity
|
13.8%
54/391 • Number of events 84 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Bladder infection(gr 3/4 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Bronchitis(gr 3/4 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Infection(gr 0/1/2 ANC)
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Infections and infestations
Pneumonia(gr 3/4 ANC)
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
CD4 lymphocytes decreased
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Laboratory test abnormal
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Leukocyte count decreased
|
4.9%
19/391 • Number of events 29 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
15/391 • Number of events 19 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Neutrophil count decreased
|
24.6%
96/391 • Number of events 173 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Platelet count decreased
|
3.1%
12/391 • Number of events 17 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Investigations
Weight loss
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.51%
2/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
6.4%
25/391 • Number of events 55 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.26%
1/391 • Number of events 6 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.0%
4/391 • Number of events 4 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
32.2%
126/391 • Number of events 306 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.26%
1/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.9%
152/391 • Number of events 400 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.26%
1/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Dizziness
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Dysgeusia
|
0.51%
2/391 • Number of events 5 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Headache
|
1.0%
4/391 • Number of events 7 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Neurological disorder NOS
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
48.1%
188/391 • Number of events 512 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Speech disorder
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Nervous system disorders
Syncope
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Psychiatric disorders
Anxiety
|
0.77%
3/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Psychiatric disorders
Depression
|
0.77%
3/391 • Number of events 8 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Psychiatric disorders
Euphoria
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Psychiatric disorders
Insomnia
|
2.6%
10/391 • Number of events 19 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Renal and urinary disorders
Urinary frequency
|
1.0%
4/391 • Number of events 7 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.77%
3/391 • Number of events 4 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.5%
6/391 • Number of events 17 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Reproductive system and breast disorders
Feminization
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.3%
9/391 • Number of events 13 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.26%
1/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis (funct/sympt)
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
10/391 • Number of events 16 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.26%
1/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
27.6%
108/391 • Number of events 217 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.26%
1/391 • Number of events 1 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Hot flashes
|
2.8%
11/391 • Number of events 23 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Hypertension
|
1.8%
7/391 • Number of events 19 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Thrombosis
|
0.77%
3/391 • Number of events 3 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
|
Vascular disorders
Vascular disorder
|
0.51%
2/391 • Number of events 2 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
—
0/0 • Up to 24 weeks
Per protocol, only Arm A patients were assessed for adverse events (i.e. Serious, and Other (Not Including Serious) Adverse Events). All-Cause Mortality is monitored for all patients.
|
Additional Information
James A. Eastham, MD
Memorial Sloan-Kettering Cancer Center
Phone: 646-422-4390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place