Radiation Therapy + Androgen Deprivation for Prostate Cancer

Recruiting at459 trial locations

Overseen by Alan Pollack, 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?

This study is evaluating whether radiation therapy is more effective than short-term androgen deprivation therapy for prostate cancer.

Research Team

Alan Pollack, MD

Principal Investigator

University of Miami

Eligibility Criteria

Men aged 18+ who've had prostate surgery for adenocarcinoma of the prostate with no lymph node involvement or unknown status, a PSA level between 0.1 and <2.0 ng/mL post-surgery, and a Gleason score ≤9. They must not have distant metastases, prior pelvic radiotherapy, other recent cancers except certain skin cancers, severe co-morbidities like heart failure or inflammatory bowel disease, HIV/AIDS, or previous allergic reactions to study drugs.

Inclusion Criteria

My cancer has not spread to distant parts of my body.

My prostate cancer was treated with surgery and either no lymph nodes were affected or their status is unknown.

My PSA levels are between 0.1 and 2.0 ng/mL after my prostate surgery.

Exclusion Criteria

I have a lump in the prostate area that might indicate cancer has returned.

I received chemotherapy before or after my prostate surgery.

I have not had certain cancer treatments like cryosurgery or radiation in the pelvic area recently.

Treatment Details

Interventions

• AA (Hormone Therapy)
• LHRH agonist (Hormone Therapy)
• Pelvic Lymph Node Radiation Therapy (Radiation Therapy)
• Prostate Radiation Therapy (Radiation Therapy)

Trial Overview This phase III trial is testing whether radiation therapy alone is as effective as combining it with short-term hormone therapy in treating men whose PSA levels are rising after prostate cancer surgery. It compares pelvic lymph node radiation with/without prostate radiation against androgen deprivation therapy plus pelvic lymph node radiation.

Participant Groups

Group I: PLNRT + PBRT + STADT Experimental Treatment 4 Interventions

Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Group II: PBRT + STAD Experimental Treatment 3 Interventions

Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Group III: PBRT Alone Active Control 1 Intervention

Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.

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

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

Cancer and Leukemia Group B

Collaborator

Trials

81

Recruited

118,000+

Dr. Richard L. Schilsky

Cancer and Leukemia Group B

Chief Executive Officer since 2012

MD from University of Chicago

Dr. Walter Stadler

Cancer and Leukemia Group B

Chief Medical Officer since 2012

MD from Harvard Medical School

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