Study on Adding Rucaparib to Enzalutamide for Men with Metastatic Prostate Cancer Resistant to Testosterone-Deprivation Therapy
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT04455750
This clinical trial is testing whether adding the drug rucaparib to enzalutamide can help treat prostate cancer that has spread and is no longer responding to testosterone-deprivation therapy. The study aims to see if this combination can help patients live longer or slow down the cancer's growth.
Patient Parameters
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Program Overview
This study is exploring whether combining two drugs, rucaparib and enzalutamide, can better treat prostate cancer that has spread to other parts of the body and is resistant to testosterone-deprivation therapy. Enzalutamide works by blocking testosterone from helping cancer cells grow, while rucaparib helps prevent cancer cells from repairing their DNA. The study will compare this combination to enzalutamide alone to see if it can help patients live longer or slow the cancer's growth. It will also investigate if certain genetic mutations can help doctors decide the best treatment for patients.
Description
The main goals of this study are to compare how long patients live without their cancer getting worse and their overall survival when treated with enzalutamide and rucaparib versus enzalutamide alone. The study will also look at the safety and side effects of the combination and how it affects patients' quality of life.
Secondary goals include examining how the combination affects cancer progression, response to treatment, and specific cancer markers. The study will also evaluate the safety of the treatment and compare different methods of detecting genetic mutations related to the cancer.
Participants will be randomly assigned to one of two groups:
- Group 1: Will take enzalutamide once daily and rucaparib twice daily. If they haven't had surgery to remove the testicles, they will also receive hormone therapy injections every 12 weeks.
- Group 2: Will take enzalutamide once daily and a placebo twice daily. If they haven't had surgery to remove the testicles, they will also receive hormone therapy injections every 12 weeks.
The treatment cycles will repeat every 28 days unless the cancer progresses or side effects become unacceptable. After finishing the study treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer.
- Must provide a tumor sample for testing.
- Cancer must be progressing despite ongoing hormone therapy or after surgery to remove the testicles.
- Must have measurable or non-measurable metastatic disease.
- No prior treatment for metastatic castration-resistant prostate cancer.
- Must have stopped certain cancer treatments for a specified time before joining the study.
- Must not have received enzalutamide, rucaparib, or similar drugs before.
- Must have good overall health and specific blood test results within normal ranges.
- Must not have active infections or other serious health conditions.
- Must not have a history of certain heart or seizure conditions.
- Must not have other active cancers, except for certain skin cancers.
- Must not be taking certain medications that interact with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
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