Proton beam therapy aims to cut prostate cancer treatment time and side effects
NCT ID NCT01950351
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a shorter course of proton beam radiation (hypofractionated) in 241 men with early-stage prostate cancer that hasn't spread. The goal is to see if this precise radiation can kill cancer cells while causing fewer bowel and bladder side effects compared to standard radiation. Researchers are tracking side effects and quality of life over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation therapy
- What this could lead to
- If successful, this could offer a more precise, shorter course of radiation for prostate cancer with fewer bowel side effects.
- What could go wrong
- This is a mid-stage trial with 241 participants, so results are not yet definitive. There is still a risk of side effects, and the approach may not work for all patients.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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241 people
The number who actually took part.
- Started
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Oct 2013
- Expected to finish
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Jun 2028
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.
- 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 diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson * History/physical examination with digital rectal examination of the prostate within 90 days prior to registration * Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration * Clinical stage T1-2b (American Joint Committee on Cancer \[AJCC\] 7th edition) and PSA \< 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy * Zubrod performance status 0-1 within 90 days prior to registration * Patient must be able to provide study-specific informed consent prior to study entry * Willingness and ability to complete the EPIC questionnaire Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years * Evidence of distant metastases * Regional lymph node involvement * Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer * Previous pelvic radiation or prostate brachytherapy * Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)
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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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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.