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

MR-targeted vs. Random TRUS-guided Prostate Biopsy

Sponsors

Lead sponsor: Fondazione del Piemonte per l'Oncologia

Source 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.

Overall Status Unknown status
Start Date November 2014
Completion Date December 2016
Primary Completion Date August 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Prostate cancer detection rate within the 3 months after MR imaging
Enrollment 90
Condition
Intervention

Intervention type: Device

Intervention name: MR-guided in-bore prostate biopsy

Description: 2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging

Arm group label: MR-targeted biopsy

Intervention type: Device

Intervention name: TRUS-guided prostate biopsy

Description: 24-28 systematic biopsy core (saturation scheme)

Arm group label: TRUS-guided biopsy

Eligibility

Criteria:

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

Gender: Male

Minimum age: 50 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Daniele Regge, MD Principal Investigator Fondazione del Piemonte per l'Oncologia
Overall Contact

Last name: Daniele Regge, MD

Phone: +39 011 9933 367

Email: [email protected]

Location
facility status contact Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute Filippo Russo, MD +39 011 9933 367 [email protected]
Location Countries

Italy

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: MR-targeted biopsy

Arm group type: Experimental

Description: 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.

Arm group label: TRUS-guided biopsy

Arm group type: Experimental

Description: Patients of arm B receive a saturation TRUS-guided prostate biopsy.

Acronym Pro-Cure2014
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov