Actively Recruiting
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Led by Mayo Clinic · Updated on 2026-01-20
118
Participants Needed
6
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.
CONDITIONS
Official Title
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by pathology report (AJCC 8th edition)
- PSA post radical prostatectomy between 0.1 and less than 2.0 ng/mL within 90 days before enrollment, obtained at least 6 weeks after surgery
- Eastern Cooperative Oncology Group performance status 0, 1, or 2 assessed within 90 days of enrollment
- Signed informed consent approved by institutional review board
- Completed all required pre-entry tests within specified time frames
- Able to start treatment (ADT or radiation) within 120 days of registration
- Age 18 years or older
- Prostate cancer up to oligometastatic disease with up to 5 sites
You will not qualify if you...
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer with PSA 0.1 ng/mL or higher
- 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
- Major medical, addictive, or psychiatric illness preventing consent, treatment completion, or follow-up
- History of myocardial infarction or decompensated congestive heart failure within the last 6 months
- On a transplant list
- More than 5 metastatic sites (more than oligometastatic disease)
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Not Yet Recruiting
3
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States, 56001
Not Yet Recruiting
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
5
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States, 54701
Not Yet Recruiting
6
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Not Yet Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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