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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707182
• Other study ID #: R22-145
• Secondary ID: 300009833
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 30, 2025
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Samuel Galgano, MD
• Phone: 205-934-1388
• Email: samuelgalgano[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 18F-rhPSMA-7.3
18F-rhPSMA-7.3 PET/MR

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of malignant lesions identified on mpMRI-guided targeted biopsy		through study completion, average 1 year
Other	Number of malignant lesions identified on PET/MRI-guided targeted biopsy		through study completion, average 1 year
Primary	Number of lesions detected in total on the participants' mpMRI exams.		through study completion, average 1 year
Secondary	Number of lesions detected on the participants' 18F-rhPSMA-7.3 exams.		through study completion, average 1 year