Prostate Cancer Clinical Trial
— PROSPET-BXOfficial title:
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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | January 1, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Humanitas Research Hospital | Rozzano |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Evangelista L, Lopci E. Re: Hendrik Van Poppel, Renée 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. — View Citation
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. — View Citation
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. — View Citation
Lopci E, Guazzoni G, Lazzeri M. (68)Ga 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. — View Citation
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. — View Citation
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. — View Citation
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 (68)Ga-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. — View Citation
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. — View Citation
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. (68)Ga-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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Standardized uptake value and Gleason Score | 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 | |
Secondary | Number of spared biopsies | 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 | |
Secondary | Cost-effectiveness | To determine the clinical utility of the "index test" compared to the "standard test in terms of cost-effectiveness. | 36 months |
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