18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer (PICture)

January 14, 2025 updated by: Radboud University Medical Center

18F-PSMA-1007 PET to Detect Primary Prostate Cancer: a Comparative Study With mpMRI and Correlation to Histopathology

To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate cancer lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with over 1.2 million new patients diagnosed every year. Since the introduction of prostate-specific antigen (PSA) the primary diagnosis consisted of histologic confirmation by transrectal ultrasound (TRUS) systematic biopsies. However, in recent years this has changed into performing multi-parametric MR imaging (mpMRI) prior to prostate biopsy.

MpMRI has proven to be a valuable tool to avoid unnecessary prostate biopsies and prevent over-treatment of low-grade PCa, while maintaining equal or higher detection rates of high-grade PCa. Prostate MRI is evaluated using the Prostate Imaging-Reporting and Data System (PIRADS). Lesions are given a category score, from 1 (high-grade PCa is unlikely to be present) to 5 (presence of high-grade PCa is highly likely). A PIRADS 3 is an equivocal scan. Nonetheless, mpMRI has room for improvement as its specificity for high-grade tumors is only 73% and local staging is limited with mpMRI. Also, the mpMRI is frequently unclear as 4-39% of detected lesions are classified as PIRADS 3.

Prostate-specific membrane antigen receptor (PSMA) is highly overexpressed by 95% of the prostate cancer cells and seem to positively correlate to aggressiveness of the tumor. PSMA-positron emission tomography (PET) uses this feature by visualizing PSMA expressing prostate tumors. Currently, the PSMA-PET is generally used to detect recurrences or metastases. However, there is an increasing interest for PSMA-PET scans in patients with a primary diagnosis of PCa for staging purposes. Yet, there is no published data on the role of PSMA-PET on PCa prior to biopsy in comparison to the detection rate of mpMRI and histopathology.

This study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of local prostate cancer lesions.

75 patients with the suspicion on prostate cancer (e.g. elevated PSA and/or abnormal digital rectal exam) will receive a 18F-PSMA-1007 PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this study.

If either the mpMRI or 18F-PSMA-1007 PET shows a potential malignant lesion, a (target) biopsy will be performed.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
  • Males ≥ 18 years
  • ECOG 0-1
  • Signed informed consent

Exclusion Criteria:

  • Prostate biopsy in the last 6 months
  • History of prostate cancer
  • Second active malignancy
  • Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
  • Any medical condition that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
  • Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIRADS 1-2
25 patients with PIRADS 1-2 (probably benign) on mpMRI
Diagnostic test: 18F-PSMA-1007 PET/CT
18F-PSMA-1007 PET/CT
Experimental: PIRADS 3
25 patients with PIRADS 3 (equivocal scan) on mpMRI
Diagnostic test: 18F-PSMA-1007 PET/CT
18F-PSMA-1007 PET/CT
Experimental: PIRADS 4-5
25 patients with PIRADS 4-5 (probably malignant) on mpMRI
Diagnostic test: 18F-PSMA-1007 PET/CT
18F-PSMA-1007 PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare mpMRI,18F-PSMA-1007 PET and histopathology.
Time Frame: 30 days
Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA-1007 PET differ is evaluated.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ABX advanced biochemical compounds GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL73559.091.20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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