MR-targeted vs. Random TRUS-guided Prostate Biopsy (Pro-Cure2014)
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|ClinicalTrials.gov Identifier: NCT02678481|
Recruitment Status : Unknown
Verified August 2016 by Fondazione del Piemonte per l'Oncologia.
Recruitment status was: Recruiting
First Posted : February 9, 2016
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: MR-guided in-bore prostate biopsy Device: TRUS-guided prostate biopsy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||November 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||December 2016|
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)
- Prostate cancer detection rate [ Time Frame: within the 3 months after MR imaging ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678481
|Contact: Daniele Regge, MD||+39 011 9933 firstname.lastname@example.org|
|Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute||Recruiting|
|Candiolo, Turin, Italy, 10060|
|Contact: Filippo Russo, MD +39 011 9933 367 email@example.com|
|Principal Investigator:||Daniele Regge, MD||Fondazione del Piemonte per l'Oncologia|