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

NCT05676463 | Terminated Phase 2 FDA Drug

• 2 other identifiers: 22D.687JT 20770
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Incidence of acute GU and gastrointestinal (GI) toxicity

  At baseline

• Incidence of acute GU and gastrointestinal (GI) toxicity

  At treatment completion, up to 10 days

• Incidence of acute GU and gastrointestinal (GI) toxicity

  every 3 months after treatment until 1 year

• Incidence of acute GU and gastrointestinal (GI) toxicity

  every 6 months beginning at year 2, assessed up to 4 years

• Incidence of late GI toxicity

  At baseline

Study Arms (1)

Treatment (MRI-guided IMRT, ADT)

EXPERIMENTAL

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.

Procedure: MRI-guided Intensity-Modulated Radiation Therapy; Drug: Antiandrogen Therapy; Procedure: PSMA PET Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan; Procedure: Biospecimen Collection; Other: Quality-of-Life Assessment

Interventions

Antiandrogen Therapy DRUG

Receive SOC ADT

Also known as: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Treatment (MRI-guided IMRT, ADT)

PSMA PET Scan PROCEDURE

Undergo PSMA PET scan

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (MRI-guided IMRT, ADT)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography, Computerized axial tomography (procedure)

Treatment (MRI-guided IMRT, ADT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging, Magnetic resonance imaging (procedure)

Treatment (MRI-guided IMRT, ADT)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Treatment (MRI-guided IMRT, ADT)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (MRI-guided IMRT, ADT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (MRI-guided IMRT, ADT)

MRI-guided Intensity-Modulated Radiation Therapy PROCEDURE

Undergo MRI-guided IMRT

Treatment (MRI-guided IMRT, ADT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Glutamate Carboxypeptidase II; Magnetic Resonance Spectroscopy; X-Rays; Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jessie DiNome, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 9, 2023
• Study Start: November 16, 2022
• Primary Completion: August 7, 2025
• Study Completion: October 24, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)