SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06205316
Phase
PHASE3
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antiandrogen Therapy — DRUG
    Receive ADT
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated radiation therapy
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT
  • Survey Administration — OTHER
    Ancillary study
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Jan 22, 2024
Status verified
Jan 2026
Primary completion
Jan 22, 2030
Completion
Jan 22, 2030

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Carlos E. Vargas, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
John Yeakel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System - MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
855-776-0015
Jason T. Hayes, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Timothy D. Malouff, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Eau Claire ClinicEau ClaireWisconsin54701
Clinical Trials Referral Office
[email protected]
855-776-0015
Now Bahar Alam, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601
Clinical Trials Referral Office
[email protected]
855-776-0015
Abigail L. Stockham, MD (PRINCIPAL_INVESTIGATOR)

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