NCT06205316Active, not recruitingPhase 3
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 118 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 4 Apr 2024
- Primary completion date
- 25 Sept 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT06205316
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 118
- From 4 Apr 2024 to the primary completion date, 25 Sept 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- Prior systemic chemotherapy for prostate cancer
- On a transplant list
Other illness
- 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)
- History of proximal urethral stricture requiring dilatation
- 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)
- History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
- More than oligometastatic disease \> 5 metastatic sites
Who the study is looking for
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] Criteria 8th edition \[Ed.\])
- PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 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 (ADT or radiation) ≤ 120 days of study registration
- Patients must be ≥ 18 years old
- Prostate cancer up to oligometastatic disease, up to 5 sites
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic Health System in Albert Lea Coordinator of this site? Confirm its status | Albert Lea | United States | Unknown status |
| Mayo Clinic Health System-Eau Claire Clinic Coordinator of this site? Confirm its status | Eau Claire | United States | Unknown status |
| Mayo Clinic Health System-Franciscan Healthcare Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| Mayo Clinic Health System Mankato Coordinator of this site? Confirm its status | Mankato | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.