Can a shorter course of radiation tame prostate cancer with fewer side effects?

NCT ID NCT01352429

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial tests two types of radiation therapy—proton therapy and IMRT—for men with low- to intermediate-risk prostate cancer. The goal is to see if a shorter, more intense radiation schedule (hypofractionation) can improve cancer control while reducing side effects. The study tracks how well patients tolerate treatment and monitors for any short- or long-term urinary or bowel issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy (proton therapy or intensity-modulated radiation therapy)
What this could lead to
If successful, this approach could offer a more convenient, shorter course of radiation with fewer side effects for men with prostate cancer.
What could go wrong
This is a mid-stage trial, so the benefits are not yet proven. There is a risk of increased side effects from the shorter radiation schedule.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

303 people

The number who actually took part.

Start date

Aug 2009

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with non-metastatic adenocarcinoma of the prostate, presenting for definitive proton or photon radiotherapy of the prostate.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Histologically confirmed prostate adenocarcinoma within 365 days of registration. * Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node \> 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested. * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with \> 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.) * PSA values \<20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy. * Zubrod (ECOG) status 0-1 documented within 90 days of registration. * Androgen deprivation is at the discretion of the treating radiation oncologist. * Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames. * Subjects must be at least 18 years old. * Members of all races and ethnic groups are eligible for this trial. Exclusion Criteria * Clinical stages T3 or greater (AJCC Criteria 6th Ed). * PSA of 20 ng/ml or greater. * Gleason score 8 or higher. * Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.) * Evidence of lymph node involvement. * Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery. * Previous pelvic radiation for prostate cancer. * Active rectal diverticulitis, Crohn's disease, or ulcerative colitis. * Prior systemic chemotherapy for prostate cancer. * History of proximal urethral stricture requiring dilatation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

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