MR-targeted vs. Random TRUS-guided Prostate Biopsy

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Device: TRUS-guided prostate biopsy; Device: MR-guided in-bore prostate biopsy

• Registration Number: NCT02678481
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-09
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

• men aged 50-80
• at least one negative TRUS-guided prostate biopsy
• PSA > 4 ng/ml
• at least one suspected region detected at multiparametric MR imaging
• signed informed consent

Exclusion Criteria

• known prostate cancer diagnosis
• contraindication against MR imaging or uncooperative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRUS-guided biopsy	TRUS-guided prostate biopsy	Patients of arm B receive a saturation TRUS-guided prostate biopsy.
MR-targeted biopsy	MR-guided in-bore prostate biopsy	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.

Primary Outcome Measures

Name	Time	Method
Prostate cancer detection rate	within the 3 months after MR imaging

Trial Locations

Locations (1)

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute; 🇮🇹 Candiolo, Turin, Italy