NCT05820724

Brief Summary

Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

April 6, 2023

Last Update Submit

April 20, 2023

Conditions

Prostate Cancer Diagnosis

Keywords

psma PETCTprostate mpMRIprostate needle biopsyDCFPyL PET/CT

Outcome Measures

Primary Outcomes (1)

  • Detection of Clinically Significant Prostate Cancer

    Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer

    12 weeks

Secondary Outcomes (5)

  • Detection of Clinically Insignificant Prostate Cancer

    12 weeks

  • Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection

    12 weeks

  • Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer

    12 weeks

  • Correlation of AI Measures with Aggressiveness of Prostate Cancer

    12 weeks

  • Adverse Events Associated with 18F- DCFPyl

    12 weeks

Study Arms (2)

PSMA PET+mpMRI

EXPERIMENTAL

PSMA PET+mpMRI guided prostate biopsy

Diagnostic Test: PSMA PET scanDrug: 18F- DCFPyl Injection

mpMRI only

ACTIVE COMPARATOR

mpMRI only guided prostate biopsy

Other: No PSMA PET

Interventions

PSMA PET scanDIAGNOSTIC_TEST

Subjects will undergo DCFPyL PET/CT imaging and mpMRI imaging prior to the prostate biopsy. The decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. The intervention includes a mpMRI, a PSMA PET scan, and a prostate biopsy.

Also known as: DCFPyL PET/CT imaging
PSMA PET+mpMRI
No PSMA PETOTHER

Subjects will undergo mpMRI imaging prior to the prostate biopsy. These subjects do not undergo a PSMA PET scan prior to the prostate biopsy. The decision for biopsy targets will be made based on the findings of mpMRI. The intervention includes a mpMRI and a prostate biopsy.

mpMRI only
18F- DCFPyl InjectionDRUG

DCFPyL is a PSMA imaging ligand that was developed to enhance the detection of small lesions in the prostate or other pelvic areas. 18F- DCFPyl Injection will be administered prior to the PSMA PET/CT via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access under the direct supervision of study personnel.

Also known as: DCFPyl
PSMA PET+mpMRI

Eligibility Criteria

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

You may qualify if:

  • Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
  • Prostate mpMRI completed within 9 months prior to enrollment
  • Patient capable of providing written informed consent
  • Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT

You may not qualify if:

  • Less than 18 years-old at the time of radiotracer administration
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
  • Creatinine clearance exceeding institutional requirements for prostate mpMRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90045, United States

Location

MeSH Terms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Study Officials

  • William Aronson, MD

    VA Greater Los Angeles Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Aronson, MD

CONTACT

310-268-3446william.aronson@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)