MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

Summary

This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.

Conditions

• Prostate Adenocarcinoma
• Stage IIIB Prostate Cancer AJCC v8
• Stage IIIC Prostate Cancer AJCC v8

Interventions

PROCEDURE

MRI-guided Intensity-Modulated Radiation Therapy

Undergo MRI-guided IMRT

DRUG

Antiandrogen Therapy

Receive SOC ADT

PROCEDURE

PSMA PET Scan

Undergo PSMA PET scan

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Jessie DiNome, MD · Thomas Jefferson University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-16

Primary Completion

2025-08-07

Completion

2025-10-24

FDA Drug

Yes

Countries

• United States

Study Locations