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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
NCT04455750 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04455750
The ClinicalTrials.gov registry entry for NCT04455750 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04455750 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alaska, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04455750?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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