Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Summary

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams.

IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects.

In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Conditions

• Prostate Cancer

Interventions

RADIATION

Proton Beam Therapy

5 days per week up to 9 weeks

RADIATION

Intensity Modulated Radiation Therapy

5 times per week up to 9 weeks

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Northwestern Medicine Chicago Proton Center

  collaborator UNKNOWN

• ProCure Proton Therapy Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Rutgers Cancer Institute of New Jersey

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  collaborator OTHER

• University of Florida Proton Therapy Institute

  collaborator UNKNOWN

• Provision Center for Proton Therapy

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Jason A Efstathiou, MD, DPhil · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-25

Primary Completion

2025-12-31

Completion

2030-12-31

Countries

• United States

Study Locations