Recruiting PHASE2 Clinical Suspicion of Prostate Cancer

New treatment option for Clinical Suspicion of Prostate Cancer

Official title Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.

ClinicalTrials.gov ID: NCT06305390

What this study is testing

What it's testing
This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, men only

You may be able to join if

  • Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
  • Feasibility to undergo all procedures listed in protocol
  • Ability to provide written informed consent

You likely can't join if

  • Prior diagnosis of prostate cancer
  • Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
  • Contraindication to prostate biopsy

The study team makes the final eligibility decision.

Where it's taking place

  • Milan, Milano, Italy

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Milan, Milano, Italy. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.