A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer

Summary

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Conditions

• Metastatic Prostate Adenocarcinoma
• Oligometastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer AJCC v8

Interventions

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

RADIATION

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Brian J. Davis, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2025-11-22

Completion

2028-11-22

FDA Device

Yes

Countries

• United States

Study Locations