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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Prostate Cancer Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type OTHER

Histoscanning™ and multiparametric MRI

Intervention Type OTHER

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

Interventions

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Histoscanning™ and multiparametric MRI

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

Intervention Type OTHER

Eligibility Criteria

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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)
* IRB-approved informed consent signed

Exclusion Criteria

* Contraindication to MRI
* Contraindication to endorectal examination
* Contraindication to prostate biopsy
* History of allergy to gadolinium chelates

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No