Study on Radiation and Hormone Therapy with Chemotherapy for Treating Castration Sensitive Oligometastatic Prostate Cancer (FAALCON)

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04748042

Provider View

This clinical trial is testing a combination of radiation therapy, hormone therapy, and chemotherapy to see if it is safe and effective for men with a specific type of prostate cancer that has spread to a few other areas but is still sensitive to hormone treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining radiation therapy with hormone therapy (ADT) and chemotherapy for treating prostate cancer. This phase 2 study focuses on delivering targeted radiation along with pulsed systemic therapy using Abiraterone, ADT, and Lynparza (olaparib) in men with castration sensitive oligometastatic prostate cancer, which means the cancer has spread to a limited number of sites and still responds to hormone therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate adenocarcinoma (not small cell or neuroendocrine types).
  • Previously had surgery or radiation aimed at curing prostate cancer.
  • Newly diagnosed with oligometastatic prostate cancer, meaning cancer has spread to 1 to 5 sites, each up to 5 cm in size.
  • No previous radiation to areas outside the prostate bed or pelvic lymph nodes.
  • PSA level greater than 0.2 ng/mL for those who had surgery, or meeting specific criteria for those who had radiation.
  • Fit for radiotherapy.
  • Cancer can be safely treated with radiation according to the oncologist.
  • Eligible for hormone therapy and Abiraterone.
  • Normal organ and bone marrow function based on recent tests.
  • Previous hormone therapy allowed if testosterone levels have recovered.
  • ECOG performance status of 0 or 1.
  • Must use a condom during treatment and for 6 months after the last dose of olaparib or abiraterone.
  • Able to give informed consent.

Exclusion Criteria

  • Previous removal of testicles.
  • Prior use of PARP inhibitors, docetaxel, or cabazitaxel.
  • Another cancer treated within the last 3 years, except certain skin or bladder cancers.
  • Life expectancy of 3 years or less.
  • Known brain metastasis.
  • Symptoms needing immediate radiation.
  • Blood disorders like MDS or AML.
  • Severe liver problems.
  • Active hepatitis infection.
  • Use of certain medications that interact with study drugs.
  • Major surgery within 2 weeks before starting treatment.
  • Significant heart disease or recent heart events.
  • Planned heart surgery.
  • Recent artery procedures.
  • Uncontrolled hormone issues.
  • Active infection or condition making prednisone use unsafe.
  • Need for high-dose steroids.
  • Previous bone marrow transplant.
  • Participation in another study recently.
  • Involvement in study planning.
  • Uncontrolled high blood pressure.
  • Allergies to study drugs.
  • Immunocompromised status.
  • Serious uncontrolled medical conditions.
  • Persistent side effects from previous cancer treatment.
  • Unable to swallow pills or have digestive issues affecting drug absorption.

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