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NCT04183699
Optimizing the Number of Systematic COres During a MRI Target Biopsy
NA trial testing Prostate biopsy in Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate in 265 participants. Currently enrolling.
30 June 2024
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 265 |
| Start date | 6 June 2019 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Prostate biopsy
Conditions studied
- Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate — all drugs for Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
Adults 18 to 80, male only, with Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores). During the same session, subsequently to MRI-TBx, patient will receive a systematic sampling with 6-core S-Bx followed by 14-core S-Bx, for a total of 20-core systematic cores, in addition to 4 MRI-TBx cores. Procedure will be performed by the same operator. Each single core will be stored in a dedicated cassette and sequentially numbered. We hypothesize that the proportion of csPCa (defined as prostate cancer with Gleason score ≥ 3+4) detected by 6-cores S-Bx will be no less than that detected by 20-cores S-Bx, both performed in addition to MRI-TBx. Assessing the optimal number of systematic cores to take in addition to MRI-TBx cores in men undergoing a MRI-TBx would provide a useful clinical information for every day clinical practice. Moreover, the possibility to decrease the number of systematic cores taken during a MRI-TBx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant PCa.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04183699
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Trials testing the same drug.
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- NCT06612047 — Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer · recruiting
- NCT06505356 — Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage · NA · enrolling by invitation
- NCT05822726 — The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer · NA · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04183699 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 12 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04183699.
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