Types of Radiation Therapy for Prostate Cancer

Recruiting at266 trial locations

Overseen by Mark K Buyyounouski

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

Research Team

Mark K Buyyounouski

Principal Investigator

NRG Oncology

Eligibility Criteria

Men who've had prostate surgery for adenocarcinoma, with certain pathology results (pT2 or pT3), and no evidence of metastasis. They must have a PSA level < 2.0 ng/mL post-surgery, good performance status, and be able to complete questionnaires in English or French. Excluded are those with prior long-term hormone therapy, other recent cancers except non-melanoma skin cancer, severe health issues like heart failure or uncontrolled infections.

Inclusion Criteria

I had surgery to remove my prostate cancer.

One of the following pathologic N-classifications: pN0, pNX

Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire

Exclusion Criteria

Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, Transmural myocardial infarction within the last 6 months, Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration, Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease, Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol, End-stage renal disease (ie, on dialysis or dialysis has been recommended), Prior allergic reaction to the study drugs involved in this protocol, History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason

I have been on hormone therapy for prostate cancer for more than 6 months before surgery.

I have received chemotherapy before or after surgery to remove my prostate.

Treatment Details

Interventions

• Hypofractionated Radiation Therapy (Radiation Therapy)
• Radiation Therapy (Radiation Therapy)

Trial Overview The trial is comparing two types of radiation therapy after prostate surgery: hypofractionated (higher doses over a shorter period) versus conventional (standard doses over a longer period). The goal is to see which method is more effective at killing tumor cells with fewer side effects.

Participant Groups

Group I: Arm II (hypofractionated radiation therapy Experimental Treatment 3 Interventions

Patients undergo hypofractionated radiation therapy for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

Group II: Arm I (conventional radiation therapy) Experimental Treatment 3 Interventions

Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

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