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
About This Trial
- This study compares two types of radiation to see if a faster, highly focused treatment can control cancer just as well while causing fewer side effects.
- It is designed for adults whose prostate cancer has returned after surgery or has spread to only a few spots in the body.
- Researchers want to find out if delivering precise radiation over fewer visits is easier on healthy tissues than standard schedules.
- Before considering this trial, patients should know that those who have already had pelvic radiation cannot take part, and the study is currently closed to new enrollment.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study compares two types of radiation to see if a faster, highly focused treatment can control cancer just as well while causing fewer side effects.
Study Details
- Start Date: April 4, 2024
- Lead Sponsor: Mayo Clinic
Full Eligibility Criteria
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 5 metastatic sites
Treatments
- Drug: Antiandrogen Therapy
- Procedure: Biospecimen Collection
- Radiation: Hypofractionated Radiation Therapy
- Procedure: Positron Emission Tomography
- Radiation: Stereotactic Body Radiation Therapy
- Other: Survey Administration
- Procedure: Magnetic Resonance Imaging