Pro-Cure2014: MR-targeted vs. Random TRUS-guided Prostate Biopsy

Sponsor

Fondazione del Piemonte per l'Oncologia (Other)

Overall Status

Unknown status

CT.gov ID

NCT02678481

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: MR-guided in-bore prostate biopsy Device: TRUS-guided prostate biopsy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: MR-guided in-bore prostate biopsy 2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
Experimental: TRUS-guided biopsy Patients of arm B receive a saturation TRUS-guided prostate biopsy.	Device: TRUS-guided prostate biopsy 24-28 systematic biopsy core (saturation scheme)

Arm

Intervention/Treatment

Experimental: 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.

Device: MR-guided in-bore prostate biopsy

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

Experimental: TRUS-guided biopsy

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

Device: TRUS-guided prostate biopsy

24-28 systematic biopsy core (saturation scheme)

Outcome Measures

Primary Outcome Measures

Prostate cancer detection rate [within the 3 months after MR imaging]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute	Candiolo	Turin	Italy	10060

Sponsors and Collaborators

Fondazione del Piemonte per l'Oncologia

Investigators

Principal Investigator: Daniele Regge, MD, Fondazione del Piemonte per l'Oncologia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione del Piemonte per l'Oncologia

ClinicalTrials.gov Identifier:

NCT02678481

Other Study ID Numbers:

Pro-Cure PCa 2014

First Posted:

Feb 9, 2016

Last Update Posted:

Aug 22, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Fondazione del Piemonte per l'Oncologia

multiparametric magnetic resonance imaging

MR-targeted prostate biopsy

saturation TRUS-guided prostate biopsy

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Aug 22, 2016