Combination Therapy for Prostate Cancer
(ASCLEPIuS Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. Specifically, you must stop taking non-steroidal anti-androgens, steroidal antiandrogens, oral ketoconazole, chemotherapy, immunotherapy, estrogens, and radiopharmaceuticals 3 months before joining the study. Additionally, spironolactone and other investigational drug therapies are prohibited 30 days before starting the study treatment.
Is the combination therapy for prostate cancer safe for humans?
How is the combination treatment for prostate cancer unique?
This combination treatment is unique because it combines multiple approaches: Abiraterone Acetate, which blocks a key enzyme to reduce hormone levels that fuel cancer growth; Leuprolide, which lowers testosterone levels; Niraparib, a PARP inhibitor that helps prevent cancer cells from repairing themselves; and Stereotactic Body Radiotherapy (SBRT), a precise form of radiation therapy. This multi-faceted approach targets prostate cancer from different angles, potentially improving outcomes compared to single treatments.36789
What data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for prostate cancer?
Who Is on the Research Team?
William Jackson, M.D.
Principal Investigator
University of Michigan Rogel Cancer Center
Daniel Spratt, M.D.
Principal Investigator
Case Western Reserve University - Seidman Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone
Treatment
Participants receive niraparib, abiraterone, leuprolide, prednisone, and SBRT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone Acetate
- Leuprolide
- Niraparib
- Stereotactic Body Radiotherapy (SBRT)
Abiraterone Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University