New radiation schedule may cut treatment time for prostate cancer patients
NCT ID NCT03570827
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a shorter course of higher-dose radiation (hypofractionation) in 53 men with high-risk prostate cancer who had already had their prostate removed. The goal was to see if this approach could control cancer while reducing side effects. Participants also received hormone therapy. The study looked at how many men remained free of cancer recurrence or needed no further treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hypofractionated radiation therapy and androgen suppression therapy
- What this could lead to
- If successful, this could offer a more convenient and potentially less toxic radiation schedule for men with high-risk prostate cancer after surgery.
- What could go wrong
- This is a small, single-arm phase II trial with only 53 participants, so results may not apply to all patients. Long-term side effects and cancer control rates are still being evaluated.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
53 people
The number who actually took part.
- Started
-
May 2018
- Finished
-
May 2025
- 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.
- 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 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 at the time of surgery * Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] criteria 8th edition \[Ed.\]) * One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and \< 2.0 * PSA values \< 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment * Patients must sign Institutional Review Board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests within the specified time frames * Patients must be able to start treatment (androgen suppression \[AS\] or radiation) within 120 days of study registration * Members of all races and ethnic groups are eligible for this trial * Patients from outside of the United States may participate in the study Exclusion Criteria: * Previous pelvic radiation * Prior androgen suppression therapy for prostate cancer for more than 6 months * Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed) * Prior systemic chemotherapy for prostate cancer * History of proximal urethral stricture requiring dilatation * Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers) * Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study) * Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed) * History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Prostate adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
-
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Walking may counteract Radiation's colon cancer risk
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?