Trial Outcomes & Findings for Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer (NCT NCT00309985)
NCT ID: NCT00309985
Last Updated: 2025-12-11
Results Overview
Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
790 participants
Primary outcome timeframe
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Results posted on
2025-12-11
Participant Flow
This study was activated on July 28, 2006, accrued its first patient on September 26, 2006, and closed to accrual on November 21, 2012, after accrual of 790 patients.
Participant milestones
| Measure |
Androgen-Deprivation Therapy and Docetaxel
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
393
|
|
Overall Study
Toxicity Analysis
|
390
|
392
|
|
Overall Study
Both Baseline and 3-month FACT-P Evals
|
334
|
299
|
|
Overall Study
COMPLETED
|
335
|
392
|
|
Overall Study
NOT COMPLETED
|
62
|
1
|
Reasons for withdrawal
| Measure |
Androgen-Deprivation Therapy and Docetaxel
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Overall Study
Disease progression
|
12
|
0
|
|
Overall Study
Adverse Event
|
30
|
0
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Never started treatment
|
7
|
0
|
|
Overall Study
Complicating disease
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
Chemotherapy discontinued only
|
1
|
0
|
Baseline Characteristics
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
Total
n=790 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=237 Participants
|
63 years
n=243 Participants
|
63 years
n=480 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
397 Participants
n=237 Participants
|
393 Participants
n=243 Participants
|
790 Participants
n=480 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entryPopulation: All randomized patients
Overall survival is defined as the time from randomization to death or date last known alive. Survival data reflects the database as of December 23, 2013.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Overall Survival
|
57.6 months
Interval 49.1 to 72.8
|
44.0 months
Interval 34.4 to 49.1
|
SECONDARY outcome
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entryPopulation: All randomized patients.
Time to clinical progression is defined as the time from randomization to clinical progression. Clinical progression is defined as increasing symptomatic bone metastases, progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinical deterioration due to cancer per investigator's opinion. Patients without documented clinical progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Time to Clinical Progression
|
33.0 months
Interval 27.3 to 41.2
|
19.8 months
Interval 17.9 to 22.8
|
SECONDARY outcome
Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entryPopulation: All randomized patients.
Time to castration resistant prostate cancer is defined as the time from randomization to PSA progression or clinical progression, whichever occurred first. Patients without documented progression were censored at the date of last disease assessment. Secondary endpoint data reflect the database as of December 23, 2014.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)
|
20.2 months
Interval 17.2 to 23.6
|
11.7 months
Interval 10.8 to 14.7
|
SECONDARY outcome
Timeframe: Assessed at 6 monthsPopulation: All randomized patients
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 6-month time point are considered as having a PSA CR at 6 months.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Proportion of Patients With PSA Complete Response (CR) at 6 Months
|
0.320 proportion of participants
Interval 0.274 to 0.369
|
0.196 proportion of participants
Interval 0.158 to 0.239
|
SECONDARY outcome
Timeframe: Assessed at 12 monthsPopulation: All randomized patients
PSA CR is defined as a PSA level less than 0.2 ng/ml measured for 2 consecutive measurements at least 4 weeks apart. Patients who met the criterion of PSA CR and had PSA level less than 0.2 ng/ml before and after the 12-month time point are considered as having a PSA CR at 12 months.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=397 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=393 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Proportion of Patients With PSA Complete Response (CR) at 12 Months
|
0.277 proportion of participants
Interval 0.234 to 0.324
|
0.168 proportion of participants
Interval 0.132 to 0.209
|
SECONDARY outcome
Timeframe: Assessed at baseline and 3 monthsPopulation: Patients with both baseline and 3-month QOL assessments are included in this analysis.
The primary QOL change was evaluated by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) instrument. FACT-P is a self-report measure of both general and disease-specific QOL. Higher scores represent better QOL. The FACT-P (version 4) contains 39 likert items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.
Outcome measures
| Measure |
Androgen-Deprivation Therapy and Docetaxel
n=334 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Androgen-Deprivation Therapy Alone
n=299 Participants
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
QOL Change From Baseline to 3 Months
|
-2.7 units on a scale
Standard Error 0.9
|
-1.1 units on a scale
Standard Error 1.0
|
Adverse Events
Arm A
Serious events: 116 serious events
Other events: 38 other events
Deaths: 0 deaths
Arm B
Serious events: 12 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=390 participants at risk
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B
n=392 participants at risk
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
2.1%
8/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
5/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Leukocytes decreased
|
4.6%
18/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Lymphopenia
|
2.3%
9/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Neutrophils decreased
|
12.1%
47/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Platelets decreased
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Vascular disorders
Hypertension
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
General disorders
Fatigue
|
4.1%
16/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Weight gain
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
General disorders
Death NOS
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Vascular disorders
Hot flashes
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Pancreatic glucose intolerance
|
0.00%
0/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.51%
2/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.0%
4/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Nausea
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
24/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, heart
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, upper airway
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection Gr0-2 neut, rectum
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Infections and infestations
Infection-other
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
General disorders
Edema limb
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Alkaline phosphatase increased
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Alanine aminotransferase increased
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Investigations
Creatinine increased
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.77%
3/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.0%
4/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Nervous system disorders
Neuropathy-motor
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Nervous system disorders
Syncope
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Cardiac disorders
Cardiac/heart, pain
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Nervous system disorders
Head/headache
|
0.00%
0/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
0.77%
3/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.51%
2/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.51%
2/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Reproductive system and breast disorders
Erectile impotence
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.51%
2/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.26%
1/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
0.00%
0/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.77%
3/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
Other adverse events
| Measure |
Arm A
n=390 participants at risk
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B
n=392 participants at risk
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
|
|---|---|---|
|
General disorders
Fatigue
|
9.0%
35/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.26%
1/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.6%
22/390 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
0.00%
0/392 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Submission of late adverse events is required at follow-up visits up to 10 years.
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60