Focal Radiation With Pulsed Systemic Therapy of Abiraterone, ADT, Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON): A Phase II, Single Arm, Single Institution Study

NCT04748042 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to assess the safety and effectiveness of radiation therapy with hormone therapy (ADT) and chemotherapy as an investigational study treatment for prostate cancer. This is a phase 2 study to deliver focal radiation with pulsed systemic therapy of Abiraterone, ADT and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer.

Details

Lead sponsor	University of Michigan Rogel Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	21
Start date	2021-05-28
Completion	2026-05

Conditions

• Prostate Cancer
• Castrate Sensitive Prostate Cancer
• Oligometastatic Disease

Interventions

• Abiraterone
• Prednisone
• External Beam Radiotherapy
• Androgen Deprivation Therapy (ADT)
• Olaparib

Primary outcomes

• Percentage of patients without treatment failure at 24 months — 24 months after enrollment
  Treatment failure is defined as one of the following: * New or progressive metastases on Computed Tomogrophy (CT)/Magnetic Resonance Imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST) * New lesion(s) on bone scan without alternate explanations (e.g. trauma, arthritis) in distribution consistent with prostate cancer metastases, by provider assessment * Clinical progression by provider assessment * Prostate Specific Antigen (PSA) doubling time under 6 months with an absolute final PSA over 1.5 ng/mL

Countries

United States