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

Fondazione del Piemonte per l'Oncologia

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: MR-guided in-bore prostate biopsy; Device: TRUS-guided prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02678481

Pro-Cure PCa 2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

MR-targeted biopsy

Experimental group

Description:

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.

Treatment:

Device: MR-guided in-bore prostate biopsy

TRUS-guided biopsy

Experimental group

Description:

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

Treatment:

Device: TRUS-guided prostate biopsy