Trial Outcomes & Findings for Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial (NCT NCT03371719)
NCT ID: NCT03371719
Last Updated: 2026-07-10
Results Overview
Biochemical progression is defined as the first occurrence of the following: * A rise in PSA ≥0.2 ng/mL from nadir PSA, confirmed by a second PSA measurement equal to or higher than the first; * Clinical or radiographic local, regional, or distant metastases * Death from any cause. Biochemical progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. Arms are compared within molecular subtype group sequentially based on a study design that determines if and how to incorporate the biomarker in a in a subsequent phase III trial.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
298 participants
Primary outcome timeframe
From randomization to biochemical progression or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.
Results posted on
2026-07-10
Participant Flow
Registered participants were required to undergo PAM50 testing to determine biomarker stratification prior in order to be randomized. Of 311 screened patients, 298 were randomized.
Participant milestones
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
155
|
|
Overall Study
Eligible population
|
141
|
154
|
|
Overall Study
COMPLETED
|
141
|
154
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial
Baseline characteristics by cohort
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
n=9 Participants
|
65.5 Years
n=27 Participants
|
65 Years
n=267 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=9 Participants
|
154 Participants
n=27 Participants
|
295 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=9 Participants
|
129 Participants
n=27 Participants
|
255 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=9 Participants
|
148 Participants
n=27 Participants
|
285 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Surgical margins
Negative
|
74 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
148 Participants
n=267 Participants
|
|
Surgical margins
Positive
|
67 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
147 Participants
n=267 Participants
|
|
Pre-RT Prostate-specific Antigen (PSA)
|
0.2 ng/mL
n=9 Participants
|
0.21 ng/mL
n=27 Participants
|
0.2 ng/mL
n=267 Participants
|
|
Pre-RT PSA Category
< 0.5 ng/mL
|
125 Participants
n=9 Participants
|
130 Participants
n=27 Participants
|
255 Participants
n=267 Participants
|
|
Pre-RT PSA Category
0.5 - 1.0 ng/mL
|
16 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
40 Participants
n=267 Participants
|
|
Combined Gleason Score
6
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
M-Stage
Other
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Combined Gleason Score
7
|
116 Participants
n=9 Participants
|
120 Participants
n=27 Participants
|
236 Participants
n=267 Participants
|
|
Combined Gleason Score
8
|
9 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
23 Participants
n=267 Participants
|
|
Combined Gleason Score
9
|
14 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Combined Gleason Score
10
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
T-Stage
T2
|
64 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
144 Participants
n=267 Participants
|
|
T-Stage
T3
|
77 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
151 Participants
n=267 Participants
|
|
N-Stage
N0
|
22 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
44 Participants
n=267 Participants
|
|
N-Stage
NX
|
119 Participants
n=9 Participants
|
132 Participants
n=27 Participants
|
251 Participants
n=267 Participants
|
|
M-Stage
M0
|
141 Participants
n=9 Participants
|
154 Participants
n=27 Participants
|
295 Participants
n=267 Participants
|
|
Decipher Score
|
0.68 scores on a scale
n=9 Participants
|
0.66 scores on a scale
n=27 Participants
|
0.67 scores on a scale
n=267 Participants
|
|
Pam50 Molecular Subtype
Luminal B
|
62 Participants
n=9 Participants
|
65 Participants
n=27 Participants
|
127 Participants
n=267 Participants
|
|
Pam50 Molecular Subtype
Luminal A/Basal/Unknown
|
79 Participants
n=9 Participants
|
89 Participants
n=27 Participants
|
168 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From randomization to biochemical progression or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.Population: Eligible participants, stratified by molecular subgroup.
Biochemical progression is defined as the first occurrence of the following: * A rise in PSA ≥0.2 ng/mL from nadir PSA, confirmed by a second PSA measurement equal to or higher than the first; * Clinical or radiographic local, regional, or distant metastases * Death from any cause. Biochemical progression-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. Arms are compared within molecular subtype group sequentially based on a study design that determines if and how to incorporate the biomarker in a in a subsequent phase III trial.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Luminal B
|
72.4 Percentage of participants
Interval 60.0 to 84.9
|
53.9 Percentage of participants
Interval 40.9 to 66.9
|
|
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Luminal A/basal/unknown
|
70.2 Percentage of participants
Interval 59.2 to 81.3
|
71.1 Percentage of participants
Interval 61.3 to 80.9
|
SECONDARY outcome
Timeframe: From randomization to death or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.Population: Eligible participants
Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants Alive (Overall Survival)
|
96.0 Percentage of participants
Interval 92.6 to 99.4
|
94.9 Percentage of participants
Interval 91.3 to 98.6
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of death due to prostate cancer or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.Population: Eligible participants
Prostate cancer death rates were estimated using the cumulative incidence method in which death from other causes is treated as a competing risk and alive patients are censored.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants Who Have Died Due to Prostate Cancer (Cancer-specific Mortality (CSM))
|
0 Percentage of participants
Confidence intervals are not estimable when estimate is 0 because no events have occurred and the variance cannot be calculated.
|
1.5 Percentage of participants
Interval 0.3 to 4.9
|
SECONDARY outcome
Timeframe: From randomization to date of first distant metastasis or death, or last follow-up if alive. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.Population: Eligible participants
Distant metastases are defined as clinical or radiographic appearance of disseminated disease. MFS rates are estimated using the Kaplan-Meier method, censoring participants alive without metastases at time of analysis.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants Alive Without Distant Metastases (Metastasis-free Survival (MFS))
|
92.1 Percentage of participants
Interval 87.4 to 96.8
|
86.2 Percentage of participants
Interval 80.5 to 91.8
|
SECONDARY outcome
Timeframe: From randomization to date of first distant metastasis or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.Population: Eligible participants
Distant metastases are defined as clinical or radiographic appearance of disseminated disease. Distant metastasis rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without distant metastases are censored at last known follow-up.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants With Distant Metastasis
|
3.9 Percentage of participants
Interval 1.5 to 8.4
|
10.3 Percentage of participants
Interval 6.0 to 15.9
|
SECONDARY outcome
Timeframe: From randomization to date of first local or regional recurrence or death, or last follow-up if alive at time of analysis. Median follow-up at time of analysis was 5.0 years. Five-year rates are presented.Population: Eligible participants
Local-regional progression is defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation. Local-regional progression rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive without local-regional progression are censored at last known follow-up.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants Wtih Local-regional Progression
|
8.2 Percentage of participants
Interval 4.2 to 13.9
|
10.4 Percentage of participants
Interval 6.1 to 16.0
|
SECONDARY outcome
Timeframe: First year of treatmentWill be compared between the two groups using a two-sample t-test.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
PSA Nadir During First Year of Treatment and Prior to Initiation of Any Hormonal Salvage Therapy
|
0.042 mg/mL
Standard Deviation 0.041
|
0.091 mg/mL
Standard Deviation 0.118
|
SECONDARY outcome
Timeframe: From randomization to initiation of salvage hormonal therapy or death, whichever occurs first, or last follow-up if alive at time of analysis. Median follow-up at time of analysis among surviving patients was 5.0 years. Five-year rates are presented.Population: Eligible participants
Initiation of salvage hormone therapy (LHRH analogues or non-study anti-androgens) that occurs after completion of SRT. Salvage hormonal therapy rates are estimated using the cumulative incidence method in which death is treated as competing risk and participants alive who have not started salvage hormonal therapy are censored at last known follow-up.
Outcome measures
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 Participants
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 Participants
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Percentage of Participants That Started Salvage Hormonal Therapy
|
5.5 Percentage of participants
Interval 2.4 to 10.4
|
18.8 Percentage of participants
Interval 12.9 to 25.7
|
SECONDARY outcome
Timeframe: One and three yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after radiation therapy, which lasts approximately 7-8 weeks from treatment start.National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to last follow-up. Median follow-up at time of analysis among surviving patients was 5.0 years.National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 monthsTestosterone levels will be reported at this time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the end of radiation therapy (approximately 7-8 weeks from treatment start) to two years.PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials, asking the patient about experience over the last seven days. Scores may reflect worst severity of the symptom (0=None, 1=Mild, 2=Moderate, 3=Severe, and 4=Very severe), frequency of the symptom (0=Never, 1=Rarely, 2=Occasionally, 3=Frequently, 4=Almost constantly), or the symptom's interference with one's "usual or daily activities" (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). The symptom row title will indicate "Severity", "Frequency", or "Interference". All scores are compared between arms; statistical analysis results are entered for p-values \< 0.05.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (Radiation Therapy, Apalutamide)
Serious events: 8 serious events
Other events: 134 other events
Deaths: 6 deaths
Arm 2 (Radiation Therapy, Placebo)
Serious events: 8 serious events
Other events: 140 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 participants at risk
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 participants at risk
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
1.3%
2/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Diarrhea
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
Chills
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
Multi-organ failure
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Infections and infestations
Infections and infestations - Other
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
Lymphocyte count decreased
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
Neutrophil count decreased
|
1.4%
2/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
White blood cell decreased
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.1%
3/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.00%
0/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Vascular disorders
Hypotension
|
0.71%
1/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
Other adverse events
| Measure |
Arm 1 (Radiation Therapy, Apalutamide)
n=141 participants at risk
External beam radiation therapy 64.8 to 70.2, 1.8-2.0 Gy/33-39 fractions over approximately 7-8 weeks. Blinded apalutamide 240mg daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
Arm 2 (Radiation Therapy, Placebo)
n=154 participants at risk
Radiation therapy as in Arm 1. Blinded placebo daily by mouth for 180 days starting day 1 of radiation therapy (+/- 14 days).
|
|---|---|---|
|
Investigations
Weight loss
|
7.1%
10/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.9%
6/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
White blood cell decreased
|
8.5%
12/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
6.5%
10/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
Pain
|
8.5%
12/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.2%
8/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.2%
5/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
11.7%
18/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
Creatinine increased
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.8%
9/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Investigations
Lymphocyte count decreased
|
16.3%
23/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
13.0%
20/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Blood and lymphatic system disorders
Anemia
|
11.3%
16/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
9.7%
15/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Endocrine disorders
Hypothyroidism
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.65%
1/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
8.4%
13/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
10/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
10.4%
16/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Diarrhea
|
40.4%
57/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
42.9%
66/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
10.6%
15/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
10.4%
16/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Nausea
|
14.2%
20/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
9.7%
15/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Proctitis
|
5.0%
7/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.8%
9/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.7%
8/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.9%
6/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Gastrointestinal disorders
Rectal pain
|
5.7%
8/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.2%
5/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
Edema limbs
|
7.1%
10/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.9%
6/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
Fatigue
|
64.5%
91/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
50.6%
78/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other
|
3.5%
5/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.8%
9/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
12/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
7.1%
11/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
10/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
12.3%
19/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
6.5%
10/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Nervous system disorders
Dizziness
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
4.5%
7/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Nervous system disorders
Dysgeusia
|
12.1%
17/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
1.3%
2/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Nervous system disorders
Headache
|
8.5%
12/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
4.5%
7/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Nervous system disorders
Memory impairment
|
5.7%
8/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
1.9%
3/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Psychiatric disorders
Insomnia
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
1.9%
3/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Psychiatric disorders
Libido decreased
|
7.1%
10/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
2.6%
4/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Cystitis noninfective
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
7.1%
11/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Dysuria
|
13.5%
19/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
13.6%
21/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Hematuria
|
14.9%
21/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
10.4%
16/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
19.1%
27/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
18.2%
28/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary frequency
|
52.5%
74/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
37.7%
58/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
40.4%
57/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
33.8%
52/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary retention
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
7.8%
12/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
6.4%
9/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
4.5%
7/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.5%
5/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.2%
8/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Renal and urinary disorders
Urinary urgency
|
37.6%
53/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
27.9%
43/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Reproductive system and breast disorders
Breast pain
|
24.8%
35/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
25.5%
36/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
27.9%
43/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Reproductive system and breast disorders
Gynecomastia
|
24.1%
34/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
2.6%
4/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
9.2%
13/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
3.2%
5/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
12/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.2%
8/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
8/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.2%
8/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
8/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
0.00%
0/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
11/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
2.6%
4/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.1%
17/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.8%
9/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.8%
35/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
9.7%
15/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
11.3%
16/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
5.8%
9/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Vascular disorders
Hot flashes
|
14.2%
20/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
15.6%
24/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
|
Vascular disorders
Hypertension
|
25.5%
36/141 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
20.8%
32/154 • From randomization to last follow-up. Median follow-up at time of analysis was 5.0 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER