SBRT vs IMRT for Prostate Cancer

Recruiting at332 trial locations

Overseen by Rodney Ellis

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 stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Research Team

Rodney Ellis

Principal Investigator

NRG Oncology

Eligibility Criteria

Men with early-stage prostate cancer (stage IIA-B) who haven't had previous treatments are eligible. They must have a prostate size less than 70 cc, specific PSA levels depending on their Gleason score, and be in good physical condition. Men over 60 can have slightly more health issues. Only English, Spanish, and French speakers who agree to fill out questionnaires can join.

Inclusion Criteria

I have prostate cancer that has not spread and hasn't been treated yet.

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

Completion of all items of the EPIC-26 at registration 60 days prior to registration

Exclusion Criteria

Presence of specific surgically implanted devices

I haven't had chemotherapy for my cancer in the last 3 years.

I have not had radiotherapy in areas that would be treated in this study.

Treatment Details

Interventions

• Intensity-Modulated Radiation Therapy (IMRT) (Radiation Therapy)
• Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy)

Trial Overview The trial is comparing two types of radiation therapy for prostate cancer: Stereotactic Body Radiation Therapy (SBRT), which targets the tumor with high precision over a few days, and Intensity-Modulated Radiation Therapy (IMRT), which shapes radiation beams to the tumor's contours.

Participant Groups

Group I: Stereotactic Body Radiation Therapy (SBRT) Experimental Treatment 1 Intervention

Patients undergo Stereotactic Body Radiation Therapy (SBRT) at least every other day for 2-3 fractions per week for 5 fractions over less than 12 business days.

Group II: Intensity-Modulated Radiation Therapy (IMRT) Active Control 1 Intervention

Patients undergo Intensity-Modulated Radiation Therapy (IMRT) once daily 5 fractions per week for 28 fractions over less than 32 business days.

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