Androgen-Deprivation + Radiation Therapy for Prostate Cancer

Recruiting at 533 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+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+