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MR-targeted vs. Random TRUS-guided Prostate Biopsy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02678481
Acronym
Pro-Cure2014
Enrollment
90
Registered
2016-02-09
Start date
2014-11-30
Completion date
2016-12-31
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

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

DEVICETRUS-guided prostate biopsy

24-28 systematic biopsy core (saturation scheme)

Sponsors

Fondazione del Piemonte per l'Oncologia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prostate cancer detection ratewithin the 3 months after MR imaging

Countries

Italy

Contacts

Primary ContactDaniele Regge, MD
daniele.regge@ircc.it+39 011 9933 367

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026