Clinical trial · Interventional
PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial
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)."
NCT05297162CI-TRIAL-00058115PROSPET-BXunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
- description
- 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.
- interventionNames
- Diagnostic Test: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
Primary outcomes (1)
- measure
- Sensitivity, Specificity, NPV, PPV, Accuracy
- timeFrame
- 36 months
- description
- 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.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDLopci 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
- BACKGROUNDLopci 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
- BACKGROUNDLopci 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
- BACKGROUNDLopci 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
- BACKGROUNDLopci 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.