PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial (PROSPET-BX)

April 27, 2022 updated by: Istituto Clinico Humanitas

Diagnostic Performance and Clinical Impact of PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer and Previously Negative Biopsy: a Head to Head, Parallel, Prospective Trial (PROSPET-BX)."

This is prospective single-arm case-control study designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate biopsy ("standard test") in men with a high suspicion of PCa after at least one negative biopsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients fulfilling inclusion criteria and providing informed consent to the study will undergo mpMRI and PSMA PET followed by software assisted fusion biopsy, performed in day-hospital setting.

The inclusion criteria are: blood PSA level >4.0ng/ml; free-to-total PSA ratio <20%; progressive rise of PSA levels in two consecutive blood samples despite antibiotics; serum blood tests suspicious for PCa; at least one previous negative biopsy (min 12 cores); ASAP and/or high-grade PIN; negative digital rectal examination.

The exclusion criteria are: antiandrogen therapy; prostate needle biopsy <21 days before PET and/or mpMRI; known active secondary cancer; endorectal coil/probe not applicable; active prostatitis; anaphylaxis against gadolinium-DOTA.

The total duration of the project is 36 months. We expect to enroll the first patient within 1 month after study activation, and complete recruitment within 30 months. Completion of all study analyses on biological materials and experimental imaging is expected within 32 months. The last period is planned for data analysis, biostatistics and manuscript preparation.

All patients eligible according to inclusion criteria and having signed the informed consent will undergo 68Ga-PSMA PET/CT and mpMRI scans within one month distance from each. Dedicated software for image visualization will be used to interpret and quantify 68Ga-PSMA PET/CT SUVmax and SUVratio. Images will be analyzed by an expert nuclear physician; who will proceed to the definition of the suspicious areas candidate to biopsy. mpMRI will be evaluated by an expert radiologist using the following phases: morphological, diffusion-weighted imaging (DWI) and spectroscopy. Reading criteria for mpMRI will be determined based on PI-RADS ver.2 [29]. Target delineation on PSMA PET and mpMRI will be performed as previously described [References].

Biopsy session will be completed within one month from 68Ga-PSMA PET/CT and mpMRI scans. Targeted TRUS-fusion needle biopsy will be performed for all lesions detected with PET and mpMRI. A subsequent randomized biopsy sampling consisting of 12 samples will be performed from the peripheral region of the prostate. The biopsy frustules will then be evaluated by an expert pathologist on PCa detection.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

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

  • Italy
      • Rozzano, Italy, 20089
        • Recruiting
        • IRCCS Humanitas Research Hospital
        • Contact:
          • Egesta Lopci, MD, PhD

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age >18 years
  • blood PSA level >4.0ng/ml;
  • free-to-total PSA ratio <20%;
  • progressive rise of PSA levels in two consecutive blood samples despite antibiotics;
  • serum blood tests suspicious for PCa;
  • at least one previous negative biopsy (min 12 cores);
  • ASAP and/or high-grade PIN;
  • negative digital rectal examination.

Exclusion Criteria:

  • antiandrogen therapy;
  • prostate needle biopsy <21 days before PET and/or mpMRI;
  • known active secondary cancer;
  • endorectal coil/probe not applicable;
  • active prostatitis;
  • anaphylaxis against gadolinium-DOTA.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
Single-arm case-control imaging trial designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate biopsy ("standard test") in men suspected for PCa after at least one negative biopsy.
Diagnostic test: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy

The prostate profile and ROIs will be drawn on PSMA PET and mpMRI and fused in real time with the TRUS image stack during biopsy. Biopsies, transrectal or transperineal according to lesion site, will be performed with patients in the dorsal lithotomy position, under antibiotic prophylaxis and local anesthesia, using 3D triplane transrectal ultrasound system (BK Medical, Analogic Ultrasound Group, Pro Focus, Transducer 8818, 6/9 MHz).

Biopsy cores will be numbered according to ROI number and topography. Specimens will be processed and evaluated by a genitourinary pathologist. Tumor foci will be quantified and graded according to the ISUP consensus conference on Gleason grading.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, Specificity, NPV, PPV, Accuracy
Time Frame: 36 months
To evaluate the diagnostic performance of PSMA PET-TRUS fusion prostate biopsy in determining the presence of PCa in comparison to mpMRI-TRUS fusion prostate biopsy analyzed in parallel in the same subset of patients.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized uptake value and Gleason Score
Time Frame: 36 months
To determine the correlations between the "index test" standardized uptake values (i.e. SUVmax, SUVratio; SUVmean) and the histopathological characteristics of the specimen (Gleason Score) in order to validate optimal cut-off points able to detect intraprostatic malignancy and differentiate clinically relevant PCa lesions.
36 months
Number of spared biopsies
Time Frame: 36 months
To determine the clinical utility of the "index test" compared to the "standard test in terms of number of spared biopsies compared to mpMRI.
36 months
Cost-effectiveness
Time Frame: 36 months
To determine the clinical utility of the "index test" compared to the "standard test in terms of cost-effectiveness.
36 months

Collaborators and Investigators

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

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Egesta Lopci, MD, PhD, IRCCS Humanitas Research Hospital

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)

April 1, 2022

Primary Completion (ANTICIPATED)

July 31, 2024

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

March 25, 2022

First Posted (ACTUAL)

March 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3131
  • GR-2018-12366240 (OTHER_GRANT: Ministero della Salute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Prostate Cancer

Clinical Trials on PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe