Spots Global Cancer Trial Database for Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

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Trial Identification

Brief Title: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Official Title: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Study ID: NCT03298087

Conditions

Newly Diagnosed Oligometastatic Prostate Cancer

Interventions

radical prostatectomy

stereotactic body radiotherapy

Leuprolide

apalutamide

abiraterone

Study Description

Brief Summary: This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Detailed Description: This is a single arm Phase II clinical trial in patients with newly diagnosed M1a,b prostate cancer and 1-5 radiographically visible metastases treated with radical prostatectomy (and post-operative fractionated radiotherapy for pT 3a, pN1, or positive margins) or radiation to the prostate, metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy. The primary endpoint of our study is the percent of patients achieving a serum PSA of \<0.05 ng/mL six months after recovery of serum testosterone (for patients undergoing radical prostatectomy) or PSA \<nadir+2 (for patients undergoing prostate radiation).