Phase 2
N=53
Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy
Prostate Adenocarcinoma · Stage IIB Prostate Cancer AJCC v8 · Stage III Prostate Cancer AJCC v8 · Stage IIIA Prostate Cancer AJCC v8 · Stage IIIB Prostate Cancer AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT03570827 ↗Enrolled (actual)
53
Serious AEs
5.7%
Results posted
May 2026
Primary outcome: Primary: Freedom From Failure (FFF) — 7; 16; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Androgen Suppression (Drug); Hypofractionated Radiation Therapy (Radiation); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Failure (FFF) |
7; 16; 5 | — |
Summary
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03570827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.