Androgen-Deprivation + Radiation Therapy for Prostate Cancer

Recruiting at533 trial locations

Overseen by Mack Roach, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Research Team

Mack Roach, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Men with moderate to high-risk prostate cancer, confirmed by biopsy within the last 180 days. They should have a PSA level under 50 ng/mL and no bone metastases. Men previously on active surveillance for low risk prostate cancer who now have higher risk disease may also join if re-biopsied within 180 days. No prior pelvic radiation or radical prostate surgery is allowed, and they must be willing to use contraception.

Inclusion Criteria

I was diagnosed with prostate cancer at moderate to high risk of coming back within the last 6 months.

ANC ≥ 1,500/mm³

Baseline serum PSA value performed within 120 days prior to registration

Exclusion Criteria

I am not willing or able to use birth control.

I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.

I have had a condition where my lymphocytes grow abnormally.

Treatment Details

Interventions

• Androgen-Deprivation Therapy (Hormone Therapy)
• Radiation Therapy (Radiation)

Trial Overview This phase III trial is testing whether combining androgen-deprivation therapy (which lowers male hormones) with whole-pelvic radiotherapy (a type of radiation that targets the entire pelvic area) is effective in treating patients with prostate cancer compared to other treatments.

Participant Groups

Group I: Arm II Experimental Treatment 1 Intervention

Patients undergo whole-pelvic radiotherapy (WPRT)\* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.

Group II: Arm I Active Control 1 Intervention

Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)\* or 3D-conformal radiation therapy (3D-CRT)\* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School