NCT05676463

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-16
• Primary completion: 2025-08-07
• Completion: 2025-10-24
• First posted: 2023-01-09
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study