Optimizing Positive Predicting Value of Prostate MRI
PROMOD
1 other identifier
observational
5,000
1 country
1
Brief Summary
The PROMOD study is an international multicenter retrospective Project. The aim is to create a comprehensive database that will include multiple heterogeneous cohorts in order to explore inter-center differences in the accuracy of Magnetic Resonance Imaging (MRI) in the diagnosis of prostate cancer and to define optimal strategies for the selection of men at risk of clinically significant prostate cancer who might benefit from biopsies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJune 16, 2022
June 1, 2022
12 months
September 22, 2021
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with clinically significant prostate cancer detected at prostate biopsy
Number of patients with histological evidence of clinically significant prostate cancer (defined as histologic Gleason Score 3+4 or higher) in prostate biopsy cores.
3 to 5 weeks
Interventions
Magnetic resonance imaging (MRI) uses a magnetic field, radiofrequency pulses, and a computer to produce detailed pictures of the organ. Prostate MRI evaluate the presence and extent of prostate cancer and determine whether it has spread around the organ
Eligibility Criteria
All patients undergoing Prostate biopsy with a pre biopsy MRI and no previous treatmens
You may qualify if:
- Patients who received prostate biopsy with a pre biopsy MRI.
You may not qualify if:
- Patients who underwent previous treatments for prostate cancer Patients who underwent post biopsy MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university ospital: Ospedali Riiuniti di Foggia
Foggia, Apulia, 70100, Italy
Related Publications (1)
Falagario UG, Lantz A, Jambor I, Busetto GM, Bettocchi C, Finati M, Ricapito A, Luzzago S, Ferro M, Musi G, Totaro A, Racioppi M, Carbonara U, Checcucci E, Manfredi M, D'Aietti D, Porcaro AB, Nordstrom T, Bjornebo L, Oderda M, Soria F, Taimen P, Aronen HJ, Perez IM, Ettala O, Marchioni M, Simone G, Ferriero M, Brassetti A, Napolitano L, Carmignani L, Signorini C, Conti A, Ludovico G, Scarcia M, Trombetta C, Claps F, Traunero F, Montanari E, Boeri L, Maggi M, Del Giudice F, Bove P, Forte V, Ficarra V, Rossanese M, Mucciardi G, Pagliarulo V, Tafuri A, Mirone V, Schips L, Antonelli A, Gontero P, Cormio L, Sciarra A, Porpiglia F, Bassi P, Ditonno P, Bostrom PJ, Messina E, Panebianco V, De Cobelli O, Carrieri G; PROMOD Study Group. Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors. World J Urol. 2023 Nov;41(11):2967-2974. doi: 10.1007/s00345-023-04634-2. Epub 2023 Oct 3.
PMID: 37787941DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Urologist
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 14, 2021
Study Start
January 1, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share