Combination Therapy for Prostate Cancer
(ASCLEPIuS Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen ByWilliam Jackson, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new combination treatment for prostate cancer. It includes a cancer drug, precise radiation, and three other medications. The goal is to find the best dose and see if it can prevent cancer from coming back over time. Docetaxel is currently the standard treatment for hormone-refractory prostate cancer.

Eligibility Criteria

Men over 18 with advanced prostate cancer, who haven't had prior treatments like radiation or anti-androgen therapy. They must have a specific grade of cancer severity, adequate organ function, and agree to use effective contraception. Exclusions include those with other recent cancers, certain heart conditions, uncontrolled diabetes or hypertension, large prostate size (>80 cc), and allergies to the trial drugs.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

My organs and bone marrow are working well.

My prostate cancer was confirmed through a biopsy.

+13 more

Exclusion Criteria

Lack of tissue from biopsy to be sent for correlative studies

My doctor has noted a significant enlargement of my prostate's median lobe.

I do not have severe heart or blood vessel problems.

+24 more

Participant Groups

The study is testing the highest dose of niraparib (a PARP inhibitor) that's safe when combined with SBRT (targeted radiotherapy), abiraterone (hormone therapy), leuprolide (hormone therapy), and prednisone in men with prostate cancer. It also aims to see how well this combination prevents cancer from returning within three years.

1Treatment groups

Experimental Treatment

Group I: Niraparid Dose EscalationExperimental Treatment4 Interventions

Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.

Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Zytiga for: