Can a shorter course of radiation tame prostate cancer with fewer side effects?
NCT ID NCT01352429
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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303 people
The number who actually took part.
- Start date
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Aug 2009
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
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Other studies related to the condition(s) this trial covers.
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- Can tracking tumor movement during radiation make treatment more precise?