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NCT01617161 · ClinicalTrials.gov registry record · NA

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

A NA study of Prostate Cancer, sponsored by Massachusetts General Hospital.

Active
Registry status
NA
Development phase
454
Enrollment target
13
Study locations

NCT01617161: Active NA study of Prostate Cancer, sponsored by Massachusetts General Hospital.

NCT01617161 is a NA study of Prostate Cancer that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 454 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (25% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01617161, a NA study of Prostate Cancer, is active but no longer recruiting, sponsored by Massachusetts General Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
454 participants
Enrollment target
13
Study locations

Study 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.

Primary Outcome

Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)

Conditions Studied

Prostate Cancer

Interventions

  • RADIATION Intensity Modulated Radiation Therapy
  • RADIATION Proton Beam Therapy

Study Locations (13)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Mass General/North Shore Cancer Center - Danvers

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick
  • Princeton ProCure Proton Therapy Center - Somerset

Florida

  • University of Florida Health Proton Therapy Institute - Jacksonville

Illinois

  • Northwestern Medicine Chicago Proton Center - Chicago

Maryland

  • University of Maryland Medical Center - College Park

Minnesota

  • Mayo Clinic - Rochester

Missouri

  • Washington University - St Louis

Ohio

  • University Hospital of Cleveland - Cleveland

Trial Details

FieldValue
Enrollment Target 454 participants
Start Date 2012-07-25
Est. Completion 2030-12
Phase NA
Massachusetts General Hospital

2,032 total trials

What the registry record for NCT01617161 still lists

NCT01617161 is an interventional study that assigns participants to a tested intervention. The registered 454 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (25% lower).

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Intensity Modulated Radiation Therapy is the first listed.

NCT01617161 lists 13 locations in 11 states (Massachusetts, New Jersey, Florida).

Frequently Asked Questions

What is clinical trial NCT01617161 about?

NCT01617161 is a clinical study titled "Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer". 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 radiatio...

What is the current status of trial NCT01617161?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 454 participants. The study started on 2012-07-25. Estimated completion is 2030-12.

What conditions does trial NCT01617161 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01617161?

The interventions under investigation include: Intensity Modulated Radiation Therapy (RADIATION), Proton Beam Therapy (RADIATION).

Who is sponsoring clinical trial NCT01617161?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01617161 being conducted?

This trial has 13 study locations across Florida, Illinois, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01617161's enrollment target sits among peer trials

454 123rd of 735 higher than 613 of 735 other Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01617161, the US trial registry maintained by the National Library of Medicine. NCT01617161 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.