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

NCT04748042 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Zachery Reichert, MD, PhD · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748042 on ClinicalTrials.gov