NCT05707182

Brief 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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
7mo left

Started Apr 2025

Shorter than P25 for early_phase_1 prostate-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

January 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

January 11, 2023

Last Update Submit

September 23, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of lesions detected in total on the participants' mpMRI exams.

    through study completion, average 1 year

Secondary Outcomes (1)

  • Number of lesions detected on the participants' 18F-rhPSMA-7.3 exams.

    through study completion, average 1 year

Other Outcomes (2)

  • 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

Study Arms (1)

Prostate Cancer

EXPERIMENTAL

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

Drug: 18F-rhPSMA-7.3

Interventions

18F-rhPSMA-7.3DRUG

18F-rhPSMA-7.3 PET/MR

Prostate Cancer

Eligibility Criteria

Age18 Years - 89 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 31, 2023

Study Start

April 30, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 25, 2024

Record last verified: 2024-09