An interventional study of MR-guided in-bore prostate biopsy and TRUS-guided prostate biopsy in Prostate Cancer, sponsored by Fondazione del Piemonte per l'Oncologia. Status unknown at 1 site in Italy. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-22.
Sponsored by Fondazione del Piemonte per l'Oncologia · Not applicable, Interventional, and Diagnostic
To compare prostate cancer (PCa) detection rate of magnetic resonance (MR)-targeted biopsy and transrectal ultrasound (TRUS)-guided biopsy in patients with high PSA values and at least one previous negative prostate biopsy. Subjects will be submitted to a multiparametric MR scan of the prostate and subsequently patients with a suspicious MR for PCa presence will be randomized (1:1) into the two study arms.
In men with previously negative prostate biopsy and persistent elevated PSA value, it is unclear which biopsy strategy offers the highest detection rate for significant PCa. The hypothesis of this study is that MR-targeted biopsy improves the detection rates of significant prostate cancers compared with systematic TRUS-guided prostate biopsy.
Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values (> 4 ng/ml) will be submitted to a multiparametric MR imaging examination of the prostate. Subsequently, participants with suspected regions at MR imaging will be randomized (1:1) into the two study arms. In study arm A patients will be submitted to MR-targeted in-bore prostate biopsy based on the multiparametric MR imaging findings. In study arm B patients will be submitted to systematic TRUS-guided prostate biopsy with saturation scheme.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 90 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Fondazione del Piemonte per l'Oncologia is the lead sponsor of 39 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MR imaging two targeted biopsy cores will be taken.
Device: MR-guided in-bore prostate biopsy
Patients of arm B receive a saturation TRUS-guided prostate biopsy.
Device: TRUS-guided prostate biopsy
2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
24-28 systematic biopsy core (saturation scheme)
Prostate cancer detection rate
Time frame: within the 3 months after MR imaging
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione del Piemonte per l'Oncologia