Recruiting
Phase 3

SBRT vs. Hypofractionated Radiotherapy

Sponsor:

Mayo Clinic

Code:

NCT06205316

Conditions

Biochemically Recurrent Prostate Carcinoma

Oligometastatic Prostate Carcinoma

Recurrent Prostate Adenocarcinoma

Stage IIB Prostate Cancer AJCC v8

Stage IIC Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antiandrogen Therapy

Biospecimen Collection

Hypofractionated Radiation Therapy

Positron Emission Tomography

Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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

Biochemically Recurrent Prostate Carcinoma

Oligometastatic Prostate Carcinoma

Recurrent Prostate Adenocarcinoma

Stage IIB Prostate Cancer AJCC v8

Stage IIC Prostate Cancer AJCC v8

Study ID

NCT06205316

Start date

Jan 22, 2024

Status verified date

Jul, 2026

Completion date

Jan 22, 2030

Anticipated

Primary completion date

Jan 22, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (SBRT)

Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.

experimental: Group II (Hypofractionated radiation therapy)

Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive androgen deprivation therapy for up to 18 months, as clinically indicated. Patients undergo PET at screening and treatment failure, and undergo blood sample collection throughout the study. Patients may also undergo MRI as clinically indicated at screening and treatment failure.

Interventions

Antiandrogen Therapy

Receive ADT

Biospecimen Collection

Undergo blood sample collection

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Positron Emission Tomography

Undergo PET scan

Stereotactic Body Radiation Therapy

Undergo SBRT

Survey Administration

Ancillary study

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

  • Incidence of grade 3 or higher genitourinary (GU)/gastrointestinal (GI) radiation treatment-related adverse events [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Carlos E. Vargas, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-08.