Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI) (ProsRSI)

A Phase II Biomarker Study of Restriction Spectrum Imaging (RSI) MRI in Patients With High-Risk, Localized Prostate Cancer Who Will Receive Radiotherapy and Androgen Deprivation Therapy

Adult male patients with high-risk, localized prostate cancer and planning to undergo radiation therapy (RT) with androgen deprivation therapy (ADT) will undergo an advanced Magnetic Resonance Imaging (MRI) examination called Restriction Spectrum Imaging (RSI-MRI) to evaluate whether RSI-MRI can predict treatment response.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Restriction Spectrum Imaging Magnetic Resonance Imaging

Detailed Description

Participants will undergo RSI at three time points: before therapy (MRI #1), after neoadjuvant ADT (MRI #2), and after radiotherapy (MRI #3). Treatment response will be assessed primarily by absence of biochemical recurrence (PSA ≥2 ng/mL greater than nadir) within 3 years of completing radiotherapy. Change in RSI cellularity index from MRI #1 to MRI #2 will be evaluated for prediction of participants who will experience biochemical recurrence within 3 years, using area under the receiver operating characteristic curve. We hypothesize that RSI cellularity index will be an early biomarker for treatment effectiveness in prostate cancer treated with ADT and radiotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michelle Padilla; Phone Number: 858-822-5223; Email: mlp002@health.ucsd.edu
• Study Contact Backup: Name: Gerald Henderson, BA; Phone Number: 858-534-4811; Email: gehenderson@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UCSD Moores Cancer Center
      • Contact: Gerald Henderson, BA; Phone Number: 858-534-4911; Email: gehenderson@ucsd.edu
      • Principal Investigator: Tyler Seibert, MD, PhD
      • Sub-Investigator: Andrew Sharabi, MD, PhD
      • Sub-Investigator: Brent Rose, MD
      • Sub-Investigator: James Urbanic, MD
      • Sub-Investigator: Arno Mundt, MD
      • Sub-Investigator: Ajay Sandhu, MD, DMRT
      • Sub-Investigator: John Einck, MD
      • Contact: Michelle Padilla; Phone Number: 858-822-5223; Email: mlp002@health.ucsd.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate
• High-risk prostate cancer (any of: PSA ≥20 ng/mL or cT3-T4 stage or Gleason score ≥8)
• Intended treatment and follow-up according to standard of care for prostate cancer
• Planning to undergo definitive radiotherapy with neoadjuvant and concurrent androgen deprivation therapy
• In good general health as evidenced by medical history and ECOG performance status 0-2
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• Prior radiotherapy to the pelvis
• Prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy)
• Hip prosthesis
• Contraindication to MRI, per institutional requirements
• Technetium-99 bone scan showing no clear evidence of distant metastasis
• MRI or CT scan of the pelvis showing no clear evidence of bone or distant metastasis
• Another malignancy, unless in remission or unlikely to impact the patient's survival or ability to receive standard care for prostate cancer (e.g., cutaneous basal cell carcinoma)
• Patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: RSI-MRI; Participants will undergo RSI-MRI at three time points: before androgen deprivation therapy (ADT); after neoadjuvant ADT but before radiation therapy (RT); and after RT.	Other: Restriction Spectrum Imaging Magnetic Resonance Imaging; RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion).; Other Names: RSI-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical recurrence (PSA 2 ng/mL greater than nadir) within 3 years of completing RT.	To evaluate the performance of the RSI cellularity index before and during therapy as a biomarker to identify participants who will experience biochemical recurrence within 3 years post-radiotherapy.	within 3 years of RT completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA nadir within the 18 months after RT ≥0.5 ng/mL.	To evaluate the performance of the RSI cellularity index for identifying participants who will fail to reach a PSA nadir <0.5 ng/mL within 18 months of RT.	within 18 months of RT completion

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Tyler Seibert, MD, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 200266

Drug and device information, study documents

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