Spots Global Cancer Trial Database for MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer

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Trial Identification

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

Official Title: Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)

Study ID: NCT05676463

Conditions

Prostate Adenocarcinoma

Stage IIIB Prostate Cancer AJCC v8

Stage IIIC Prostate Cancer AJCC v8

Interventions

MRI-guided Intensity-Modulated Radiation Therapy

Antiandrogen Therapy

PSMA PET Scan

Computed Tomography

Magnetic Resonance Imaging

Bone Scan

Biospecimen Collection

Quality-of-Life Assessment

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVE: I. Evaluate late grade 2+ genitourinary (GU) toxicity. SECONDARY OBJECTIVE: I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life. OUTLINE: Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.