Saruparib + ARPI for Prostate Cancer
(EvoPAR-PR05 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new drug combination for men with metastatic hormone-sensitive prostate cancer. Researchers compare saruparib, a potential new drug, combined with a standard prostate cancer treatment (such as enzalutamide, darolutamide, or abiraterone) against a placebo with the same standard treatments. The study seeks participants diagnosed with this type of prostate cancer, previously treated with docetaxel or PSMA-directed therapy, whose disease has not progressed. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that saruparib is currently being tested for safety and effectiveness in treating certain cancers, including prostate cancer. Detailed information about its safety in humans from other studies is not yet available. This trial is in a later stage, indicating some safety has been demonstrated in earlier tests.
For treatments like abiraterone, enzalutamide, and darolutamide, which target the androgen receptor pathway, more is known about their safety. These drugs have already received approval for treating various forms of prostate cancer. Studies have found them to be generally well-tolerated, although some patients may experience side effects such as tiredness or high blood pressure. Medical help can usually manage these side effects.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, which typically include drugs like enzalutamide, darolutamide, and abiraterone, Saruparib stands out because it targets cancer cells with precision. Saruparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to cancer cell death. This mechanism is different from existing ARPI drugs that primarily block hormones fueling cancer growth. Researchers are excited because combining Saruparib with these standard treatments could enhance their effectiveness, offering hope for better outcomes in prostate cancer management.
What evidence suggests that this trial's treatments could be effective for metastatic hormone-sensitive prostate cancer?
Research has shown that saruparib, a PARP inhibitor, may help treat prostate cancer. PARP inhibitors block an enzyme that cancer cells need to repair their DNA. Studies have found that these drugs can slow cancer growth, especially in patients with certain genetic changes. This trial will test saruparib combined with a physician's choice of abiraterone, darolutamide, or enzalutamide, well-known prostate cancer treatments. These treatments lower testosterone levels, which the cancer needs to grow. Combining saruparib with one of these treatments might enhance effectiveness by attacking the cancer in different ways.
Are You a Good Fit for This Trial?
This trial is for men with metastatic hormone-sensitive prostate cancer who have already been treated with docetaxel chemo or PSMA-targeted radioligand therapy, have no signs of disease getting worse, and have a PSA level of at least 0.2 ng/mL.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive saruparib or placebo in combination with physician's choice of ARPI in cycles of 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Darolutamide
- Enzalutamide
- Saruparib
Trial Overview
The study compares saruparib plus a doctor-chosen ARPI (like enzalutamide, darolutamide, or abiraterone) to placebo plus the same ARPI. Participants are randomly assigned to each group to see which treatment works better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days
Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
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