Shorter, stronger radiation for prostate cancer shows promise in new trial
NCT ID NCT03987386
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a shorter, higher-dose radiation schedule (hypofractionated) works as well as the standard longer course for men with prostate cancer who have had surgery. About 186 men will be randomly assigned to one of the two radiation plans. The study tracks side effects, cancer control, and quality of life to see if the shorter approach is safer and just as effective.
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 (hypofractionated vs. conventional)
- What this could lead to
- If successful, this could offer a more convenient, shorter course of radiation after prostate cancer surgery with fewer side effects.
- What could go wrong
- This is a mid-stage trial with 186 participants, so results may not apply to all patients. The higher-dose approach could also increase some side effects.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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186 people
The number who actually took part.
- Started
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May 2019
- Expected to finish
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Nov 2027
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: * Men age 18 or older * Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted * Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology * For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of \>= 0.1. PSA \>= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT) * Patient diagnosed with Gleason score of 6-10 * Eastern Cooperative Oncology Group (ECOG) performance 0-2 * Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy * If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer Exclusion Criteria: * Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region * Neoadjuvant chemotherapy before or after prostatectomy * History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome * History of severe active co-morbidity or uncontrolled diabetes * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease * End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
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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
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MD Anderson League City
League City, Texas, 77573, United States
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MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double-Dose precision: new combo radiation aims to shrink prostate tumors faster