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

NCT05297162 | Unknown DMC

• 2 other identifiers: 3131GR-2018-12366240
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

PSMA PET/CT; Primary Diagnosis; multiparametric MRI

Outcome Measures

Primary Outcomes (1)

• Sensitivity, Specificity, NPV, PPV, Accuracy

  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 Outcomes (3)

• Standardized uptake value and Gleason Score

  36 months

• Number of spared biopsies

  36 months

• Cost-effectiveness

  36 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, 20089, Italy

RECRUITING

Related Publications (9)

• Lopci E, Lughezzani G, Castello A, Saita A, Colombo P, Hurle R, Peschechera R, Benetti A, Zandegiacomo S, Pasini L, Casale P, Pietro D, Bevilacqua G, Balzarini L, Buffi NM, Guazzoni G, Lazzeri M. Prospective Evaluation of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography in Primary Prostate Cancer Diagnosis. Eur Urol Focus. 2021 Jul;7(4):764-771. doi: 10.1016/j.euf.2020.03.004. Epub 2020 Apr 17.

  PMID: 32312701 BACKGROUND

• Lopci E, Lughezzani G, Castello A, Colombo P, Casale P, Saita A, Buffi NM, Guazzoni G, Chiti A, Lazzeri M. PSMA-PET and micro-ultrasound potential in the diagnostic pathway of prostate cancer. Clin Transl Oncol. 2021 Jan;23(1):172-178. doi: 10.1007/s12094-020-02384-w. Epub 2020 May 23.

  PMID: 32447644 BACKGROUND

• Lopci E, Saita A, Lazzeri M, Lughezzani G, Colombo P, Buffi NM, Hurle R, Marzo K, Peschechera R, Benetti A, Zandegiacomo S, Pasini L, Lista G, Cardone P, Castello A, Maffei D, Balzarini L, Chiti A, Guazzoni G, Casale P. 68Ga-PSMA Positron Emission Tomography/Computerized Tomography for Primary Diagnosis of Prostate Cancer in Men with Contraindications to or Negative Multiparametric Magnetic Resonance Imaging: A Prospective Observational Study. J Urol. 2018 Jul;200(1):95-103. doi: 10.1016/j.juro.2018.01.079. Epub 2018 Feb 1.

  PMID: 29409824 BACKGROUND

• Lopci E, Lazzeri M. Re: Michael S. Hofman, Nathan Lawrentschuk, Roslyn J. Francis, et al. Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study. Lancet 2020;395:1208-16: PSMA Positron Emission Tomography: One Tracer Fixes Them All! Eur Urol. 2020 Sep;78(3):e131-e132. doi: 10.1016/j.eururo.2020.06.054. Epub 2020 Jul 9. No abstract available.

  PMID: 32653324 BACKGROUND

• Lopci E, Colombo P, Lazzeri M. Mismatched Imaging Findings of Prostate Cancer Diagnosis: 68 Ga-PSMA PET/CT vs mpMRI. Nucl Med Mol Imaging. 2021 Aug;55(4):199-202. doi: 10.1007/s13139-021-00701-x. Epub 2021 Jun 2.

  PMID: 34422131 BACKGROUND

• Lopci E, Piccardo A, Lazzeri M. Prostate cancer imaging and therapeutic alternatives with highly specific molecular 'probes'. BJU Int. 2019 Aug;124(2):188-189. doi: 10.1111/bju.14713. Epub 2019 Mar 14. No abstract available.

  PMID: 30785658 BACKGROUND

• Lopci E, Guazzoni G, Lazzeri M. 68Ga Prostate-specific Membrane Antigen PET/CT for Primary Diagnosis of Prostate Cancer: Complementary or Alternative to Multiparametric MR Imaging. Radiology. 2018 May;287(2):725-726. doi: 10.1148/radiol.2017172607. No abstract available.

  PMID: 29668418 BACKGROUND

• Lazzeri M, Lopci E, Lughezzani G, Colombo P, Casale P, Hurle R, Saita A, Leonardi L, Lista G, Peschechera R, Pasini L, Rodari M, Zandegiacomo S, Benetti A, Cardone P, Mrakic F, Balzarini L, Chiti A, Guazzoni G, Buffi NM. Targeted 11C-choline PET-CT/TRUS software fusion-guided prostate biopsy in men with persistently elevated PSA and negative mpMRI after previous negative biopsy. Eur J Hybrid Imaging. 2017;1(1):9. doi: 10.1186/s41824-017-0011-1. Epub 2017 Nov 1.

  PMID: 29782590 BACKGROUND

• Evangelista L, Lopci E. Re: Hendrik Van Poppel, Renee Hogenhout, Peter Albers, et al. Early Detection of Prostate Cancer in 2020 and Beyond: Facts and Recommendations for the European Union and the European Commission. Eur Urol 2021;79:327-9: Early Detection of Prostate Cancer in High-risk Patients with Negative Fusion Biopsy. Eur Urol. 2021 Jul;80(1):e24-e27. doi: 10.1016/j.eururo.2021.04.026. Epub 2021 May 2. No abstract available.

  PMID: 33947593 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Egesta Lopci, MD, PhD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Egesta Lopci, MD, PhD

CONTACT

+390282247542; egesta.lopci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: January 1, 2025
• Last Updated: April 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)