Clinical Trials Directory

Trials / Completed

CompletedNCT01857037

Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI

Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

Inclusion criteria: * Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR * Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence) Study Design: * Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI. * Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images. * Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion). * Histoscanning™ and MRI results will be compared to biopsy results. A total of 30 patients will be included

Conditions

Interventions

TypeNameDescription
OTHERHistoscanning™ and multiparametric MRIDetection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI

Timeline

Start date
2011-05-01
Primary completion
2014-08-01
Completion
2014-08-01
First posted
2013-05-20
Last updated
2025-09-03

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01857037. Inclusion in this directory is not an endorsement.