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SBRT vs. Hypofractionated Radiotherapy for Recurrent or Oligometastatic Prostate Cancer

This study is comparing two types of radiation therapy for men with prostate cancer that has returned (recurrent) or spread to a limited number of areas (oligometastatic). The treatments being studied are Stereotactic Body Radiation Therapy (SBRT) and hypofractionated radiation therapy. SBRT uses special equipment to deliver precise radiation to tumors, aiming to protect healthy tissues. The main goal is to see if SBRT causes similar or fewer serious side effects in the urinary and digestive systems compared to hypofractionated radiation therapy within two years. Men aged 18 and older with confirmed prostate cancer that has returned after surgery and meets specific PSA levels may be eligible. The study plans to enroll 118 participants, but its current status is unclear.

Study design
This is a phase III interventional study comparing two radiation therapies in 118 male participants.
What's involved
Participants will undergo blood sample collection, PET scans, and receive either SBRT or hypofractionated radiation therapy, potentially with antiandrogen therapy.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years to monitor for serious side effects, and for up to five years for other outcomes like disease-free survival and quality of life.

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NCT06205316

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
Mayo Clinic
~118 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Antiandrogen TherapyBiospecimen CollectionHypofractionated Radiation TherapyPositron Emission TomographyStereotactic Body Radiation TherapySurvey Administration

At a glance

Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events
Measured over Up to 2 years

Conditions

Biochemically Recurrent Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Recurrent Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8

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Prostate Carcinoma

Where it's being run

6 sites across 3 states
Minnesota3
Wisconsin2
Arizona1

Study leadership

  • Carlos E. Vargas, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

Previous pelvic radiation
Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
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 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
On a transplant list
More than oligometastatic disease \> 5 metastatic sites

What this trial measures

  • Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse eventsUp to 2 years

    Defined as the proportion of patients experiencing an increase in GU/GI Common Terminology Criteria for Adverse Events version 5.0 to grade 3+ compared to pre-radiation therapy GU/GI toxicity over the number of patients eligible for toxicity evaluation at 2 years from the start of radiation therapy. This endpoint will be compared between patients treated with stereotactic body radiation therapy and hypofractionated radiation therapy.