NCT02678481

MR-targeted vs. Random TRUS-guided Prostate Biopsy

MR-targeted vs. Random TRUS-guided Prostate Biopsy in Patients With High PSA Values and Previous Negative Biopsy Results: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	MR-guided in-bore prostate biopsy	2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
DEVICE	TRUS-guided prostate biopsy	24-28 systematic biopsy core (saturation scheme)

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-08-01
• Completion: 2016-12-01
• First posted: 2016-02-09
• Last updated: 2016-08-22

Locations

1 site across 1 country: Italy