NCT04748042

Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer
• Castrate Sensitive Prostate Cancer
• Oligometastatic Disease

Interventions

Type	Name	Description
DRUG	Abiraterone	Abiraterone 1000 mg by mouth per day for approximately 6 months.
DRUG	Prednisone	Prednisone 5 mg by mouth per day for approximately 6 months.
RADIATION	External Beam Radiotherapy	External beam radiotherapy, dose will depend on lesion location. Completed within 40 days of study start.
BIOLOGICAL	Androgen Deprivation Therapy (ADT)	ADT by luteinizing hormone-releasing hormone (LHRH) agonist or antagonist for 6 months.
DRUG	Olaparib	Olaparib tablets 300 mg by mouth twice a day for approximately 5 months.

Timeline

• Start date: 2021-05-28
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-02-10
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study