MR-targeted vs. Random TRUS-guided Prostate Biopsy

NCT02678481 | Unknown

• 1 other identifier: Pro-Cure PCa 2014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

multiparametric magnetic resonance imaging; MR-targeted prostate biopsy; saturation TRUS-guided prostate biopsy

Outcome Measures

Primary Outcomes (1)

• Prostate cancer detection rate

  within the 3 months after MR imaging

Study Arms (2)

MR-targeted biopsy

EXPERIMENTAL

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

TRUS-guided biopsy

EXPERIMENTAL

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

Device: TRUS-guided prostate biopsy

Interventions

MR-guided in-bore prostate biopsy DEVICE

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

MR-targeted biopsy

TRUS-guided prostate biopsy DEVICE

24-28 systematic biopsy core (saturation scheme)

TRUS-guided biopsy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute

Candiolo, Turin, 10060, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniele Regge, MD

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Regge, MD

CONTACT

+39 011 9933 367; daniele.regge@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)