Prostate CancerPROSPET-BXNCT05297162
PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial
A study testing PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy in people with Prostate Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, 20089
Egesta Lopci, MD, PhD
About this study
Official 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
- Keywords
- PSMA PET/CT, Primary Diagnosis, multiparametric MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (3)
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.
Measured: 36 months
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.
Measured: 36 months
Cost-effectiveness
To determine the clinical utility of the "index test" compared to the "standard test in terms of cost-effectiveness.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Egesta Lopci, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297162
- Sponsor's protocol ID
- 3131
- Other IDs
- GR-2018-12366240
- Acronym
- PROSPET-BX
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32312701Lopci 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.
PubMed 32447644Lopci 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.
PubMed 29409824Lopci 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.
PubMed 32653324Lopci 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.
PubMed 34422131Lopci 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.
PubMed 30785658Lopci 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.
PubMed 29668418Lazzeri 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.
PubMed 29782590Evangelista 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.
PubMed 33947593Lopci E, Saitta C, Saita A, Vanni E, Santandrea A, Disconzi L, Fasulo V, Buffi N, Lazzeri M, Lughezzani G. Cost Analysis of PSMA-PET in the PROSPET-BX Trial. Cancers (Basel). 2026 Mar 2;18(5):806. doi: 10.3390/cancers18050806.
PubMed 41827740Lopci E, Lazzeri M, Saita A, Saitta C, Disconzi L, Colombo P, Fasulo V, Tarullo G, Vuono E, Peschechera R, Zanca R, Jandric J, Sposta FM, Scapaticci E, Paciotti M, Hurle R, Benetti A, Avolio PP, Cieri M, Zandegiacomo S, Pasini L, Casale P, Guazzoni G, Balzarini L, Laghi A, Buffi NM, Lughezzani G. [68Ga]PSMA-11 PET/CT vs. mpMRI in patients with a high suspicion of prostate cancer and previous negative biopsy: head to head, parallel, prospective trial (PROSPET-BX). Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4424-4435. doi: 10.1007/s00259-026-07829-y. Epub 2026 Mar 5.
PubMed 41784782
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)."
- ClinicalTrials.gov ID
- NCT05297162
- Acronym / sponsor ID
- PROSPET-BX / 3131
- Conditions
- Prostate Cancer
- Keywords
- PSMA PET/CT, Primary Diagnosis, multiparametric MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy | Experimental | Diagnostic Test: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsySingle-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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- antiandrogen therapy;
- prostate needle biopsy <21 days before PET and/or mpMRI;
- known active secondary cancer;
- endorectal coil/probe not applicable;
- active prostatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsyThe 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. | Diagnostic test | PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy |
Primary outcome
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.
3 secondary outcomes
Standardized uptake value and Gleason Score
Time frame: 36 months
Number of spared biopsies
Time frame: 36 months
Cost-effectiveness
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 32312701Lopci 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.
- Background: PubMed 32447644Lopci 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.
- Background: PubMed 29409824Lopci 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.
- Background: PubMed 32653324Lopci 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.
- Background: PubMed 34422131Lopci 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.
- Background: PubMed 30785658Lopci 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.
- Background: PubMed 29668418Lopci 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.
- Background: PubMed 29782590Lazzeri 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.
- Background: PubMed 33947593Evangelista 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.
- Derived from this study: PubMed 41827740Lopci E, Saitta C, Saita A, Vanni E, Santandrea A, Disconzi L, Fasulo V, Buffi N, Lazzeri M, Lughezzani G. Cost Analysis of PSMA-PET in the PROSPET-BX Trial. Cancers (Basel). 2026 Mar 2;18(5):806. doi: 10.3390/cancers18050806.
- Derived from this study: PubMed 41784782Lopci E, Lazzeri M, Saita A, Saitta C, Disconzi L, Colombo P, Fasulo V, Tarullo G, Vuono E, Peschechera R, Zanca R, Jandric J, Sposta FM, Scapaticci E, Paciotti M, Hurle R, Benetti A, Avolio PP, Cieri M, Zandegiacomo S, Pasini L, Casale P, Guazzoni G, Balzarini L, Laghi A, Buffi NM, Lughezzani G. [68Ga]PSMA-11 PET/CT vs. mpMRI in patients with a high suspicion of prostate cancer and previous negative biopsy: head to head, parallel, prospective trial (PROSPET-BX). Eur J Nucl Med Mol Imaging. 2026 Jun;53(7):4424-4435. doi: 10.1007/s00259-026-07829-y. Epub 2026 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egesta Lopci, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy in people with Prostate Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Egesta Lopci, MD, PhD (+390282247542, egesta.lopci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, NPV, PPV, Accuracy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297162, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.