Androgen Suppression With Abiraterone, Leuprolide, PARP Inhibitor and Stereotactic Radiotherapy in Prostate Cancer (ASCLEPIuS)

About the Study

This study will look at treating men with high risk prostate cancer using the PARP inhibitor, niraparib combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone. Phase 1 of this study will look at the best dose of niraparib for this treatment combination. The phase 2 portion of this study will look at the 3-year PSA recurrence free-survival rate of the patients who received this combined therapy.

What the Study Entails

This is an open label, single-group study.

• All participants will receive the same study combination and will know which treatments they are receiving. 

All study participants will receive the following:

• Niraparib will be administered orally once per day on a dose escalation schedule to determine the most tolerable and effective dosage (although Niraparib will be withheld for several days before, during, and after SBRT when administered in the lower doses).
• Abiraterone acetate will be administered orally every day.
• Leuprolide will be administered once every three months via an intramuscular injection.
• Prednisone will be given orally twice per day, or at the clinic’s discretion.
• Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
• Study participants will be followed up to 5 years after their first dose of Niraparib.

Study Locations

Michigan
Ann Arbor, MI
University of Michigan Rogel Cancer Center    
Contact: Cancer AnswerLine: 800-865-1125
or by email at:  [email protected]  
Principal Investigator: William Jackson, MD       

New York
New York, NY
Weill Cornell Medicine
Contact: Sharanya Chandrasekhar, MS: 646-962-2196
or by email at:  [email protected]     
Contact: Pragya Yadav, PhD: 646-962-2199
or by email at: [email protected]        
Principal Investigator: Himanshu Nagar, MD      

Ohio
Cleveland, OH
University Hospitals Seidman Cancer Center 
Contact: Daniel Spratt, MD:  216-293-6191      
or by email at: [email protected]
Principal Investigator: Daniel Spratt, MD        

Texas
Dallas, TX
University of Texas Southwestern   
Contact: Cancer AnswerLine at UTSW: 833-722-6237 
or by email at: [email protected]     
Principal Investigator: Neil Desai, MD, MHS           

Men age 18 years or older who meet the following criteria:

• Has prostate cancer (already confirmed with a biopsy) and meets Gleason score grade group and PSA test criteria as defined by the study team, with at least one of the following criteria:
  • cN1 on conventional or PET imaging
  • Grade group 5
  • Grade group 4 and PSA ≥10 ng/mL
  • Grade group 3 and PSA ≥20 ng/mL
  • High probability of Radiographic T3 on MRI AND Grade group ≥2
  • Grade Group 3 AND PSA ≥10 ng/mL AND ≥50% positive biopsy cores
• Tissue available for DNA testing

People with the following are not eligible:

• Evidence of metastatic disease by CT/bone scan
• Had prior pelvic radiation therapy
• Significant heart disease
• Lack of available tissue from biopsy
• Had prior treatment for prostate cancer (including TURP, chemotherapy, radiation therapy, or anti-androgen therapy)