Trial Outcomes & Findings for Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy (NCT NCT02203695)
NCT ID: NCT02203695
Last Updated: 2025-10-28
Results Overview
The primary efficacy endpoint is the rate of Freedom-from-PSA-progression (FFPP) at 2-years. FFPP is defined as the time from randomization to the date of PSA progression. A subject who does not have PSA progression at the time of the analysis will be censored at the last date of PSA measurement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
From time of randomization to date of PSA progression, approximately 2 years.
Results posted on
2025-10-28
Participant Flow
Participant milestones
| Measure |
SRT Plus Enzalutamide
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
SRT Plus Enzalutamide
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Overall Study
Patient withdrew consent
|
1
|
1
|
|
Overall Study
Started non-study treatment
|
1
|
0
|
Baseline Characteristics
Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
Baseline characteristics by cohort
| Measure |
SRT Plus Enzalutamide
n=43 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=43 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 Years
n=5 Participants
|
66 Years
n=7 Participants
|
67 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
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of randomization to date of PSA progression, approximately 2 years.The primary efficacy endpoint is the rate of Freedom-from-PSA-progression (FFPP) at 2-years. FFPP is defined as the time from randomization to the date of PSA progression. A subject who does not have PSA progression at the time of the analysis will be censored at the last date of PSA measurement.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=43 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=43 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Percent of Participants With Freedom of PSA (Prostate Specific Antigen) Progression
|
84 Percent of patients with no progession
|
66 Percent of patients with no progession
|
SECONDARY outcome
Timeframe: 2 years from end of radiation therapyLocal recurrence within the radiation field (confirmed pathologically) at 2-years
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=43 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=43 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Number of Participants With Local Recurrence
|
0 Participants with local recurrence
|
0 Participants with local recurrence
|
SECONDARY outcome
Timeframe: 2 years from the time of registrationMetastasis-free survival (MFS) rates at 2 years. Metastasis-free survival will be defined as the time from the date of registration to date of evidence of systemic disease on bone scan or cross sectional imaging or death, which occurs first. Number of participants with a metastasis event at 2 years is reported.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=43 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=43 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Metastatic Free Survival Rate
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (180 Days) and 6 Months Post-treatmentPopulation: Participants with data collected
The European Organization for the Research and Treatment of Cancer (EORTC-QLQ-P25) quality of life questionnaire, Prostate Cancer Module. Uses a 4-point Likert scale, with responses ranging from "not at all" to "very much" for sexual symptoms and treatment related symptoms. Domain scores range 0 to 100, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=11 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=11 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
Baseline-Sexual Symptoms
|
53.70 score on a scale
Standard Deviation 44.56
|
41.67 score on a scale
Standard Deviation 10.39
|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
End of Treatment (180 days) -Sexual Symptoms
|
59.72 score on a scale
Standard Deviation 38.32
|
42.22 score on a scale
Standard Deviation 11.52
|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
6 Months Post-treatment-Sexual Symptoms
|
35.19 score on a scale
Standard Deviation 22.45
|
35.19 score on a scale
Standard Deviation 3.21
|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
Baseline-Treatment related Symptoms
|
9.09 score on a scale
Standard Deviation 24.85
|
4.04 score on a scale
Standard Deviation 3.59
|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
End of treatment (180 days) -Treatment related Symptoms
|
14.44 score on a scale
Standard Deviation 8.77
|
3.09 score on a scale
Standard Deviation 2.92
|
|
How Well Participants Tolerate Treatment Assessed by European Organization for Research & Treatment of Cancer Quality of Life (Questionnaire (EORTC-QLQ-P25)
6 Months Post-treatment-Treatment Related Symptoms
|
11.11 score on a scale
Standard Deviation 6.42
|
1.39 score on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (180 Days) and 6 Months Post-treatmentPopulation: Participants with data collected
The Functional Assessment of Cancer Therapy (FACT-P), assesses the health-related quality of life in men with prostate cancer. The score is the sum of all 5 domain scores and ranges from 0 to156 where higher scores represent better quality of life.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=11 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=11 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
Baseline
|
126.15 score on a scale
Standard Deviation 13.06
|
129 score on a scale
Standard Deviation 15.54
|
|
How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
End of Treament (180 Days)
|
123.40 score on a scale
Standard Deviation 12.02
|
124.33 score on a scale
Standard Deviation 21.90
|
|
How Well Participants Tolerate Treatment Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P).
6 months Post-Treament
|
126.86 score on a scale
Standard Deviation 13.69
|
137.25 score on a scale
Standard Deviation 4.03
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (180 Days) and 6 Months Post-treatmentPopulation: Participants with data collected
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire score range is from 0 to 100. A higher score indicates a better level of functioning or quality of life.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=11 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=11 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Baseline-Physical Functioning
|
92.22 score on a scale
Standard Deviation 10.68
|
100. score on a scale
Standard Deviation 0.00
|
|
How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
End of Treatment - (180 Days) Physical Functioning
|
95.33 score on a scale
Standard Deviation 8.92
|
97.04 score on a scale
Standard Deviation 6.76
|
|
How Well Participants Tolerate Treatment Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
6 Months Post-treatment - Physical Functioning
|
92.22 score on a scale
Standard Deviation 10.68
|
100. score on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (180 Days) and 6 Months Post-treatmentPopulation: Participants with data collected
Quality of life (QoL) tool used to determine participant tolerability of treatment assessed by Sexual Health inventory in Men (SHIM). The questionnaire includes 5-items, and provides a total score from 1 to 25, with higher scores indicating better erectile function and lower scores indicating more severe erectile dysfunction.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=11 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=11 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire.
Baseline
|
7.36 score on a scale
Standard Deviation 9.16
|
12.27 score on a scale
Standard Deviation 10.97
|
|
How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire.
End of Treatment (180 days)
|
4.8 score on a scale
Standard Deviation 7.55
|
10.89 score on a scale
Standard Deviation 9.48
|
|
How Well Participants Tolerate Treatment Assessed by Sexual Health Inventory in Men (SHIM) Questionnaire.
6 months Post-Treatment
|
6.14 score on a scale
Standard Deviation 9.46
|
16.25 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The Overall Number of Participants analyzed represents the goal of 48 participants in each arm.
Anticipated accrual of participants versus actual reported enrollment. The goal is 48 in each arm.
Outcome measures
| Measure |
SRT Plus Enzalutamide
n=48 Participants
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=48 Participants
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Feasibility of Achieving Stated Accrual
|
43 Participants
|
43 Participants
|
Adverse Events
SRT Plus Enzalutamide
Serious events: 0 serious events
Other events: 43 other events
Deaths: 2 deaths
SRT Plus Placebo
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SRT Plus Enzalutamide
n=43 participants at risk
Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
Enzalutamide: Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
|
SRT Plus Placebo
n=43 participants at risk
Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
SRT: Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
|
|---|---|---|
|
Nervous system disorders
nocturia
|
30.2%
13/43 • Number of events 13 • Up to 2 years
|
30.2%
13/43 • Number of events 13 • Up to 2 years
|
|
Blood and lymphatic system disorders
lymphopenia
|
9.3%
4/43 • Number of events 4 • Up to 2 years
|
4.7%
2/43 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
erectile dysfunction
|
18.6%
8/43 • Number of events 8 • Up to 2 years
|
20.9%
9/43 • Number of events 9 • Up to 2 years
|
|
General disorders
hypertension
|
20.9%
9/43 • Number of events 9 • Up to 2 years
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
|
General disorders
fall
|
0.00%
0/43 • Up to 2 years
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
|
General disorders
humerus fracture
|
0.00%
0/43 • Up to 2 years
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
|
General disorders
fatigue
|
65.1%
28/43 • Number of events 28 • Up to 2 years
|
53.5%
23/43 • Number of events 23 • Up to 2 years
|
|
Renal and urinary disorders
urinary frequency/urgency
|
39.5%
17/43 • Number of events 17 • Up to 2 years
|
48.8%
21/43 • Number of events 21 • Up to 2 years
|
|
Gastrointestinal disorders
diarrhea
|
30.2%
13/43 • Number of events 13 • Up to 2 years
|
25.6%
11/43 • Number of events 11 • Up to 2 years
|
|
General disorders
breast and nipple pain
|
25.6%
11/43 • Number of events 11 • Up to 2 years
|
0.00%
0/43 • Up to 2 years
|
|
General disorders
sexuality alteration
|
27.9%
12/43 • Number of events 12 • Up to 2 years
|
20.9%
9/43 • Number of events 9 • Up to 2 years
|
|
Renal and urinary disorders
urinary incontinence
|
9.3%
4/43 • Number of events 4 • Up to 2 years
|
23.3%
10/43 • Number of events 10 • Up to 2 years
|
|
Psychiatric disorders
Anorexia
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
hemmorrhoids
|
20.9%
9/43 • Number of events 9 • Up to 2 years
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
|
Endocrine disorders
hot flashes
|
16.3%
7/43 • Number of events 7 • Up to 2 years
|
14.0%
6/43 • Number of events 6 • Up to 2 years
|
|
Endocrine disorders
hyperglycemia
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
9.3%
4/43 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
nausea
|
14.0%
6/43 • Number of events 6 • Up to 2 years
|
4.7%
2/43 • Number of events 2 • Up to 2 years
|
|
General disorders
pain (due to XRT)
|
14.0%
6/43 • Number of events 6 • Up to 2 years
|
9.3%
4/43 • Number of events 4 • Up to 2 years
|
|
General disorders
Proctitis
|
14.0%
6/43 • Number of events 6 • Up to 2 years
|
2.3%
1/43 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
11.6%
5/43 • Number of events 5 • Up to 2 years
|
Additional Information
Dr. Daniel Song
Johns Hopkins University, School of Medicine
Phone: 410-502-5875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place