18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: a Pilot Study

The purpose of this study is to investigate the usefulness of PET/MRI with an investigational radioactive drug, 18F-rhPSMA-7.3, and MRI contrast in evaluating patients with prostate cancer eligible for active surveillance. This study is for imaging purposes only and is not a treatment study.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 18F-rhPSMA-7.3

Detailed Description

Prostate cancer is the most common non-cutaneous malignancy in American men with the majority of men diagnosed with PSA-based screening. As such, many will be found to have low-risk disease when detected early in the disease course. Whole gland radical therapies with primary curative intent are typically invasive and incur a recognized risk of morbidity, particularly in regards to urinary and sexual quality of life measures. For this reason, patients with competing comorbidities or low risk disease have increasingly approached management with active surveillance. The use of active surveillance has increased significantly, particularly in those patients with low-volume, low-grade prostate cancer. For these surveillance protocols, serial PSA biomarker evaluation and periodic repeat prostate biopsies are scheduled to assess for grade or stage progression which may redirect management toward curative treatment options within the window for cure. Since the advent of prostate indication multi-parametric MRI (mpMRI) and its use to target areas of suspicion for biopsy sampling, MRI-TRUS fusion biopsy has been used in the setting of patients with active surveillance to better characterize disease risk stratification for confirmatory biopsy sampling.

Despite the advances mpMRI has offered, its sensitivity for detection of clinically significant prostate cancer is insufficient to replace biopsy at both initial diagnosis and during active surveillance. Additionally, although MRI-TRUS fusion has improved detection of clinically significant cancers, it is known that a fraction of prostate cancers remain occult on mpMRI. Various PSMA radiotracers have been explored as an alternative to mpMRI for the detection of clinically significant prostate cancer. Many of these studies utilize PET/CT, which does not take advantage of the vast superiority of mpMRI over CT and limits their ability to detect clinically significant prostate cancer. However, early studies utilizing PET/MRI (in which the sensitivity of the exam for clinically significant cancer is improved by both the PET and MRI components) have shown promising results. While these studies have explored the role of PSMA-PET/MRI in lesion detection and biopsy guidance, there is little data regarding its use in the setting of active surveillance.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Recruiting
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men with biopsy-confirmed low risk or favorable intermediate risk prostate cancer who are scheduled to undergo multiparametric prostate MRI and confirmatory biopsy as per institutional active surveillance protocol.

Exclusion Criteria:

• Biopsy-proven prostate cancer not eligible for active surveillance per institutional criteria.
• Current or prior treatment for prostate cancer.
• Suspected prostate cancer without histologic confirmation.
• Inability to undergo 3 Tesla prostate MRI due to claustrophobia and/or MRI- incompatible devices or MR incompatible metal implants.

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: Prostate Cancer; 18F-rhPSMA-7.3 PET/MRI in Prostate Cancer Active Surveillance: A Pilot Study	Drug: 18F-rhPSMA-7.3; 18F-rhPSMA-7.3 PET/MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of lesions detected in total on the participants' mpMRI exams.	through study completion, average 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of lesions detected on the participants' 18F-rhPSMA-7.3 exams.	through study completion, average 1 year

Other Outcome Measures

Outcome Measure	Time Frame
Number of malignant lesions identified on mpMRI-guided targeted biopsy	through study completion, average 1 year
Number of malignant lesions identified on PET/MRI-guided targeted biopsy	through study completion, average 1 year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 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: R22-145; 300009833 (Other Identifier: UAB IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No