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

Prostate Cancer Recurrent Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

• NCT number: NCT01857037
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Completion date: August 2014