MR-targeted vs. Random TRUS-guided Prostate Biopsy

Prostate Cancer Clinical Trial

— Pro-Cure2014  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678481
• Other study ID #: Pro-Cure PCa 2014
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2016
• Last updated: August 19, 2016
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Daniele Regge, MD
• Phone: +39 011 9933 367
• Email: daniele.regge[@]ircc.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• MR-guided in-bore prostate biopsy
2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
• TRUS-guided prostate biopsy
24-28 systematic biopsy core (saturation scheme)

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute	Candiolo	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer detection rate		within the 3 months after MR imaging	No