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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
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Prostate cancer detection rate [ Time Frame: within the 3 months after MR imaging ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Daniele Regge, MD +39 011 9933 367 daniele.regge@ircc.it

Locations
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Italy
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute Recruiting
Candiolo, Turin, Italy, 10060
Contact: Filippo Russo, MD    +39 011 9933 367    filippo.russo@ircc.it   
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
Investigators
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Principal Investigator: Daniele Regge, MD Fondazione del Piemonte per l'Oncologia
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Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02678481    
Other Study ID Numbers: Pro-Cure PCa 2014
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases