Rucaparib + Enzalutamide for Prostate Cancer
(CASPAR Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that are strong inhibitors of CYP2C8 or inducers of CYP3A4 enzymes before joining. You should also closely monitor any medications that are substrates of CYP3A4, CYP2C9, and CYP2C19 enzymes with your doctor.
What data supports the effectiveness of the drug combination Rucaparib + Enzalutamide for prostate cancer?
Is the combination of Rucaparib and Enzalutamide safe for humans?
Enzalutamide, used for prostate cancer, has been shown to be generally safe in humans, but it can cause side effects like fatigue and, in rare cases, severe issues like low platelet counts (thrombocytopenia) and seizures. There is no specific safety data available for the combination of Rucaparib and Enzalutamide.16789
How is the drug combination of Rucaparib and Enzalutamide unique for prostate cancer treatment?
The combination of Rucaparib and Enzalutamide is unique because Rucaparib targets DNA damage repair gene alterations, such as BRCA1 or BRCA2, which are common in metastatic castration-resistant prostate cancer, while Enzalutamide is an antiandrogen that helps block the effects of male hormones that can promote cancer growth. This dual approach targets both genetic vulnerabilities and hormone-driven cancer growth.1341011
Research Team
Arpit Rao, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
Men with metastatic prostate cancer resistant to testosterone-deprivation therapy are eligible. They must have documented prostate adenocarcinoma, radiographic progression, and no central nervous system metastases that aren't stable or treated. Participants need to be off certain drugs affecting liver enzymes and recovered from major surgeries or treatments. No prior treatment for metastatic castration-resistant prostate cancer is allowed.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enzalutamide and rucaparib or enzalutamide and placebo, with androgen deprivation therapy if applicable. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months for 2 years, then every 6 months for 3 years.
Treatment Details
Interventions
- Enzalutamide
- Rucaparib camsylate
Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator