SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

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
• Stage III Prostate Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8

Interventions

DRUG

Antiandrogen Therapy

Receive ADT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

RADIATION

Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

OTHER

Survey Administration

Ancillary study

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Carlos E. Vargas, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-22

Primary Completion

2030-01-22

Completion

2030-01-22

Countries

• United States

Study Locations