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NCT03371719 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial
A Phase 2 study of Recurrent Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT03371719: Active Phase 2 study of Recurrent Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, sponsored by NRG Oncology.
NCT03371719 is a Phase 2 study of Recurrent Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7 that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 324 participants, above the 154-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03371719, a Phase 2 study of Recurrent Prostate Carcinoma and Stage IV Prostate Adenocarcinoma AJCC v7, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.
Primary Outcome
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 stud
Conditions Studied
Interventions
- RADIATION External Beam Radiation Therapy
- DRUG Apalutamide
- OTHER Placebo Administration
Study Locations (20)
California
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Marin General Hospital - Greenbrae
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Gene Upshaw Memorial Tahoe Forest Cancer Center - Truckee
- Sutter Solano Medical Center/Cancer Center - Vallejo
Colorado
- UCHealth University of Colorado Hospital - Aurora
- Penrose-Saint Francis Healthcare - Colorado Springs
- UCHealth Memorial Hospital Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- Poudre Valley Hospital - Fort Collins
Arizona
- Arizona Center for Cancer Care - Gilbert - Gilbert
- Arizona Center for Cancer Care-Peoria - Peoria
- Arizona Center for Cancer Care - Scottsdale - Scottsdale
- Arizona Center for Cancer Care-Surprise - Surprise
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What the registry record for NCT03371719 still lists
NCT03371719 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 29 other Recurrent Prostate Carcinoma trials with a reported enrollment target (110% higher).
The record links to 3 conditions, with Recurrent Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which External Beam Radiation Therapy is the first listed.
NCT03371719 names 20 study sites across 4 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT03371719 about?
NCT03371719 is a clinical study titled "Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial". This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. D...
What is the current status of trial NCT03371719?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2018-06-20. Estimated completion is 2026-03-01.
What conditions does trial NCT03371719 study?
This clinical trial studies the following conditions: Recurrent Prostate Carcinoma, Stage IV Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7.
What interventions are being tested in trial NCT03371719?
The interventions under investigation include: External Beam Radiation Therapy (RADIATION), Apalutamide (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT03371719?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03371719 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Prostate Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03371719's enrollment target sits among peer trials
324 3rd of 29 higher than 27 of 29 other Recurrent Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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