Trial Outcomes & Findings for Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (NCT NCT00544830)
NCT ID: NCT00544830
Last Updated: 2025-05-07
Results Overview
Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to \> 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is \> 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is \> 3.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)
Results posted on
2025-05-07
Participant Flow
The first patient was consented on July 18, 2006. The last eligible patient was consented on August 25, 2010. Patients were recruited at City of Hope National Medical Center.
Participant milestones
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=93 Participants
|
|
Age, Continuous
|
66.9 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=93 Participants
|
|
Baseline Prostate Specific Antigen (PSA)
|
11.4 ng/ml
n=93 Participants
|
|
Metastases limited to pelvic lymph nodes
|
8 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)Population: Metastatic prostate cancer patients treated with androgen deprivation.
Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to \> 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is \> 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is \> 3.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Time to Prostate-specific Antigen (PSA) Relapse
|
16.5 month
Interval 14.0 to 34.3
|
SECONDARY outcome
Timeframe: During the time period between on-study PSA to off-study PSA, up to 36 weeks.Population: Patients who achieved PSA nadir of \< 0.2 at 36 weeks.
Number of Patients who achieved PSA nadir of \< 0.2 at 36 weeks.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.
|
25 Participants
|
SECONDARY outcome
Timeframe: Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.Population: Metastatic prostate cancer patients treated with androgen deprivation therapy.
Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).
|
15 Participants
|
SECONDARY outcome
Timeframe: Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 monthsPopulation: Patients with hormone sensitive prostate cancer
Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Length of Follow-up
|
111.4 week
Interval 58.1 to 264.8
|
SECONDARY outcome
Timeframe: after 36 week LHRH treatment window.Population: Patients with metastases limited to pelvic lymph nodes
Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=8 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Count of Patients Remaining Off of Therapy
|
7 Participants
|
SECONDARY outcome
Timeframe: Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.Population: Patients with metastases limited to pelvic lymph nodes.
Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=8 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.
|
14.7 month
Interval 9.2 to 46.4
|
SECONDARY outcome
Timeframe: after 36 weeks of LHRH therapy.Population: Patients with metastases limited to pelvic lymph nodes.
Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.
Outcome measures
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=8 Participants
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.
|
4 Participants
|
Adverse Events
Treatment (Androgen Therapy, Radiation Therapy)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 participants at risk
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Gastrointestinal disorders
10012727 -- Diarrhea
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
10010300 -- Confusion
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Androgen Therapy, Radiation Therapy)
n=29 participants at risk
ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy.
RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.
Bicalutamide: Given PO
Goserelin Acetate: Given SC
Intensity-Modulated Radiation Therapy: Undergo IMRT
Laboratory Biomarker Analysis: Correlative studies
Leuprolide Acetate: Given via injection
|
|---|---|
|
Blood and lymphatic system disorders
10019483 -- Hemoglobin decreased
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
10003658 -- Atrial fibrillation
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
10003668 -- Atrial tachycardia
|
3.4%
1/29 • Number of events 1
|
|
Cardiac disorders
10040741 -- Sinus bradycardia
|
20.7%
6/29 • Number of events 6
|
|
Ear and labyrinth disorders
10019246 -- Hearing loss
|
3.4%
1/29 • Number of events 1
|
|
Endocrine disorders
10014695 -- Endocrine disorder
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10000081 -- Abdominal pain
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10010774 -- Constipation
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
10012727 -- Diarrhea
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
10013950 -- Dysphagia
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
10015461 -- Esophagitis
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10016766 -- Flatulence
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
10017944 -- Gastrointestinal disorder
|
13.8%
4/29 • Number of events 4
|
|
Gastrointestinal disorders
10018286 -- Gingival pain
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10019611 -- Hemorrhoids
|
27.6%
8/29 • Number of events 8
|
|
Gastrointestinal disorders
10028813 -- Nausea
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10036774 -- Proctitis
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10036787 -- Proctoscopy abnormal
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10038064 -- Rectal hemorrhage
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
10038072 -- Rectal pain
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10047700 -- Vomiting
|
6.9%
2/29 • Number of events 2
|
|
Gastrointestinal disorders
10056848 -- Ear, nose and throat examination abnormal
|
3.4%
1/29 • Number of events 1
|
|
Gastrointestinal disorders
10065709 -- Rectal necrosis
|
3.4%
1/29 • Number of events 1
|
|
General disorders
10008479 -- Chest pain
|
6.9%
2/29 • Number of events 2
|
|
General disorders
10016256 -- Fatigue
|
48.3%
14/29 • Number of events 14
|
|
General disorders
10016558 -- Fever
|
3.4%
1/29 • Number of events 1
|
|
General disorders
10033371 -- Pain
|
3.4%
1/29 • Number of events 1
|
|
General disorders
10050068 -- Edema limbs
|
13.8%
4/29 • Number of events 4
|
|
General disorders
90004082 -- Pain
|
3.4%
1/29 • Number of events 1
|
|
General disorders
10008531 -- Chills
|
3.4%
1/29 • Number of events 1
|
|
Immune system disorders
10020751 -- Hypersensitivity
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
10021789 -- Infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
90031098 -- Upper respiratory infection
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
90031102 -- Urinary tract infection
|
3.4%
1/29 • Number of events 1
|
|
Injury, poisoning and procedural complications
10061103 -- Dermatitis radiation
|
3.4%
1/29 • Number of events 1
|
|
Injury, poisoning and procedural complications
10065892 -- Small intestinal anastomotic leak
|
3.4%
1/29 • Number of events 1
|
|
Investigations
10001551 -- Alanine aminotransferase increased
|
20.7%
6/29 • Number of events 6
|
|
Investigations
10001675 -- Alkaline phosphatase increased
|
3.4%
1/29 • Number of events 1
|
|
Investigations
10003481 -- Aspartate aminotransferase increased
|
31.0%
9/29 • Number of events 9
|
|
Investigations
10011349 -- Creatine phosphokinase increased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10011368 -- Creatinine increased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10025256 -- Lymphocyte count decreased
|
62.1%
18/29 • Number of events 18
|
|
Investigations
10029366 -- Neutrophil count decreased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10035528 -- Platelet count decreased
|
3.4%
1/29 • Number of events 1
|
|
Investigations
10040190 -- Serum cholesterol increased
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10047896 -- Weight gain
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10048552 -- Leukocyte count decreased
|
62.1%
18/29 • Number of events 18
|
|
Investigations
10024384 -- Leukopenia
|
6.9%
2/29 • Number of events 2
|
|
Investigations
10025327 -- Lymphopenia
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10002646 -- Anorexia
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
10005557 -- Blood glucose increased
|
34.5%
10/29 • Number of events 10
|
|
Metabolism and nutrition disorders
10012174 -- Dehydration
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10040123 -- Serum albumin decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10040175 -- Serum calcium increased
|
20.7%
6/29 • Number of events 6
|
|
Metabolism and nutrition disorders
10040268 -- Serum glucose decreased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
10040336 -- Serum magnesium decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10040378 -- Serum potassium decreased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10040379 -- Serum potassium increased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
10040405 -- Serum sodium increased
|
3.4%
1/29 • Number of events 1
|
|
Metabolism and nutrition disorders
10040424 -- Serum triglycerides increased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
10054863 -- Serum sodium decreased
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
10021018 -- Hypokalemia
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
10003246 -- Arthritis
|
13.8%
4/29 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
10003988 -- Back pain
|
24.1%
7/29 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
10006002 -- Bone pain
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
10023222 -- Joint pain
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
10028411 -- Myalgia
|
3.4%
1/29 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
10028836 -- Neck pain
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
10031282 -- Osteoporosis
|
10.3%
3/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
10033425 -- Pain in extremity
|
6.9%
2/29 • Number of events 2
|
|
Nervous system disorders
10013573 -- Dizziness
|
6.9%
2/29 • Number of events 2
|
|
Nervous system disorders
10019211 -- Headache
|
6.9%
2/29 • Number of events 2
|
|
Nervous system disorders
10029298 -- Neurological disorder NOS
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
10034620 -- Peripheral sensory neuropathy
|
10.3%
3/29 • Number of events 3
|
|
Psychiatric disorders
10002855 -- Anxiety
|
13.8%
4/29 • Number of events 4
|
|
Psychiatric disorders
10012378 -- Depression
|
3.4%
1/29 • Number of events 1
|
|
Psychiatric disorders
10022437 -- Insomnia
|
6.9%
2/29 • Number of events 2
|
|
Psychiatric disorders
10024419 -- Libido decreased
|
6.9%
2/29 • Number of events 2
|
|
Renal and urinary disorders
10011781 -- Cystitis
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
10019591 -- Hemorrhage urinary tract
|
13.8%
4/29 • Number of events 4
|
|
Renal and urinary disorders
10037020 -- Protein urine positive
|
6.9%
2/29 • Number of events 2
|
|
Renal and urinary disorders
10038435 -- Renal failure
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
10046461 -- Urethral pain
|
13.8%
4/29 • Number of events 4
|
|
Renal and urinary disorders
10046539 -- Urinary frequency
|
75.9%
22/29 • Number of events 22
|
|
Renal and urinary disorders
10046543 -- Urinary incontinence
|
20.7%
6/29 • Number of events 6
|
|
Renal and urinary disorders
10046555 -- Urinary retention
|
13.8%
4/29 • Number of events 4
|
|
Renal and urinary disorders
10046694 -- Urogenital disorder
|
3.4%
1/29 • Number of events 1
|
|
Reproductive system and breast disorders
10034310 -- Penile pain
|
3.4%
1/29 • Number of events 1
|
|
Reproductive system and breast disorders
10036968 -- Prostatic pain
|
3.4%
1/29 • Number of events 1
|
|
Reproductive system and breast disorders
10061461 -- Erectile dysfunction
|
34.5%
10/29 • Number of events 10
|
|
Reproductive system and breast disorders
10018801 -- Gynecomastia
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
10011224 -- Cough
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
10013963 -- Dyspnea
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
10034844 -- Pharyngolaryngeal pain
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
10035598 -- Pleural effusion
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
10047681 -- Voice alteration
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
10001760 -- Alopecia
|
6.9%
2/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
10013786 -- Dry skin
|
10.3%
3/29 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
10037087 -- Pruritus
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
10037853 -- Rash desquamating
|
17.2%
5/29 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
10040831 -- Skin disorder
|
3.4%
1/29 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
10040865 -- Skin hyperpigmentation
|
6.9%
2/29 • Number of events 2
|
|
Vascular disorders
10020407 -- Hot flashes
|
3.4%
1/29 • Number of events 1
|
|
Vascular disorders
10020772 -- Hypertension
|
3.4%
1/29 • Number of events 1
|
|
Vascular disorders
10021097 -- Hypotension
|
3.4%
1/29 • Number of events 1
|
Additional Information
Dr. Cy Stein
City of Hope
Phone: 626-359-8111
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place