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

NCT01857037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-03

No results posted yet for this study

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

  • Prostate Cancer Recurrent

Interventions

OTHER

Histoscanning™ and multiparametric MRI

Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Olivier Rouvière, Pr · Hospices Civiles de Lyon

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857037 on ClinicalTrials.gov