MR-targeted vs. Random TRUS-guided Prostate Biopsy

NCT ID: NCT02678481

Last Updated: 2016-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MR-targeted 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.

Group Type: EXPERIMENTAL

MR-guided in-bore prostate biopsy

Intervention Type: DEVICE

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

TRUS-guided biopsy

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

Group Type: EXPERIMENTAL

TRUS-guided prostate biopsy

Intervention Type: DEVICE

24-28 systematic biopsy core (saturation scheme)

Interventions

MR-guided in-bore prostate biopsy

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

Intervention Type: DEVICE

TRUS-guided prostate biopsy

24-28 systematic biopsy core (saturation scheme)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniele Regge, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia

Locations

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Daniele Regge, MD

Role: CONTACT

daniele.regge@ircc.it

+39 011 9933 367

Facility Contacts

Filippo Russo, MD

Role: primary

filippo.russo@ircc.it

+39 011 9933 367

Other Identifiers

Pro-Cure PCa 2014

Identifier Type: -

Identifier Source: org_study_id