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NCT04455750 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
A Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT04455750: Active Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT04455750 is a Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 61 participants, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04455750, a Phase 3 study of Stage IVB Prostate Cancer AJCC v8 and Castration-Resistant Prostate Carcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized, placebo-controlled phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient.
Primary Outcome
Radiographic progression-free survival (rPFS) is defined as the time from randomization to date of disease progression or death due to any cause. rPFS time will be compared between the treatment arms using a log-rank test. Median times per treatment arms will be reported.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Enzalutamide
- DRUG Goserelin Acetate
- DRUG Leuprolide Acetate
- DRUG Rucaparib camsylate
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT04455750 still lists
NCT04455750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 176-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (65% lower).
The record links to 5 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04455750 names 20 study sites across 4 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT04455750 about?
NCT04455750 is a clinical study titled "A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy". This randomized, placebo-controlled phase III trial is evaluating the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-de...
What is the current status of trial NCT04455750?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2021-10-14. Estimated completion is 2027-09.
What conditions does trial NCT04455750 study?
This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma.
What interventions are being tested in trial NCT04455750?
The interventions under investigation include: Placebo (DRUG), Enzalutamide (DRUG), Goserelin Acetate (DRUG), Leuprolide Acetate (DRUG), Rucaparib camsylate (DRUG).
Who is sponsoring clinical trial NCT04455750?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04455750 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IVB Prostate Cancer AJCC v8
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 NCT04455750's enrollment target sits among peer trials
61 22nd of 45 higher than 23 of 45 other Stage IVB Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 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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