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)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Adenocarcinoma; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: MRI-guided Intensity-Modulated Radiation Therapy; Drug: Antiandrogen Therapy; Procedure: PSMA PET Scan

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: above 18 years
• Participants must be histologically proven, adenocarcinoma prostate
• Localized to the prostate without positive pelvic lymph node involvement
• No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan
• High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL
• Ability to receive long term hormone therapy
• Karnofsky performance score (KPS) > 70
• No prior history of therapeutic irradiation to pelvis
• Patient willing and reliable for follow-up and quality of life (QOL)
• English speaking/reading

Exclusion Criteria:

• Evidence of distant or pelvic metastasis at any time since presentation
• Life expectancy < 2 years
• Previous radiation therapy (RT) to prostate or prostatectomy
• A previous trans-urethral resection of the prostate (TURP)
• Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT
• Patients with known obstructive symptoms with stricture
• Any contraindication to radiotherapy such as inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (MRI-guided IMRT, ADT); Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Magnetic Resonance Imaging; Undergo MRI; Other Names: MRI; Magnetic Resonance; Magnetic Resonance Imaging Scan; MR; MR Imaging; MRI Scan; NMR Imaging; NMRI; Medical Imaging; Magnetic Resonance / Nuclear Magnetic Resonance; nuclear magnetic resonance imaging; Magnetic resonance imaging (procedure); Procedure: Computed Tomography; Undergo CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Tomography; tomography; CT SCAN; computerized axial tomography; Computerized axial tomography (procedure); Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: Bone Scan; Undergo bone scan; Other Names: Bone Scintigraphy; Procedure: MRI-guided Intensity-Modulated Radiation Therapy; Undergo MRI-guided IMRT; Drug: Antiandrogen Therapy; Receive SOC ADT; Other Names: ADT; Androgen Deprivation Therapy; Anti-androgen Therapy; Anti-androgen Treatment; Antiandrogen Treatment; Hormone Deprivation Therapy; Hormone-Deprivation Therapy; Androgen Deprivation Therapy (ADT); Procedure: PSMA PET Scan; Undergo PSMA PET scan; Other Names: PSMA PET; Prostate-specific Membrane Antigen PET; PSMA-Positron emission tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of late grade 2+ genitourinary (GU) toxicity	Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At baseline
Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At treatment completion, up to 10 days
Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 3 months after treatment until 1 year
Incidence of acute GU and gastrointestinal (GI) toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 6 months beginning at year 2, assessed up to 4 years
Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At baseline
Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	At treatment completion, up to 10 days
Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 3 months after treatment until 1 year
Incidence of late GI toxicity	Will be estimated using a binomial proportion and exact 95% confidence interval.	every 6 months beginning at year 2, assessed up to 4 years
Overall survival	Will be estimated using the Kaplan-Meier method.	At baseline
Overall survival	Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Overall survival	Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Overall survival	Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	At baseline
Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Prostate cancer specific survival	Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	At baseline
Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	At treatment completion, up to 10 days
Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	every 3 months after treatment until 1 year
Biochemical failure	Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.	every 6 months beginning at year 2, assessed up to 4 years
Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	At baseline
Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	At treatment completion, up to 10 days
Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	every 3 months after treatment until 1 year
Quality of life measurement	Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.	every 6 months beginning at year 2, assessed up to 4 years

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Jessie DiNome, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): August 7, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Pharmacologic Actions; Chemical Actions and Uses; Physical Phenomena; Hydrolases; Enzymes; Enzymes and Coenzymes; Chemistry Techniques, Analytical; Spectrum Analysis; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Peptide Hydrolases; Metalloproteases; Carboxypeptidases; Exopeptidases; Metalloexopeptidases; Androgen Antagonists; Specimen Handling; Magnetic Resonance Spectroscopy; X-Rays; Glutamate Carboxypeptidase II
• Other Study ID Numbers: 22D.687; JT 20770 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No