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

Not Applicable

Completed

• Conditions: Prostate Cancer Recurrent
• Interventions: Other: Histoscanning™ and multiparametric MRI

• Registration Number: NCT01857037
• Lead Sponsor: Hospices Civils de Lyon

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-05
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2015-02-26
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Histoscanning™ and multiparametric MRI	Single arm

Primary Outcome Measures

Name	Time	Method
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.	1 day	Histoscanning and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of Histoscanning to correctly identify the presence or absence of cancer into prostate sextants.

Secondary Outcome Measures

Name	Time	Method
Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.	1 day	MRI and biopsy findings will be compared on a sextant by sextant basis. A mixed effects logistic regression model (with fixed and random effects) will be used to model the sensitivity and specificity of MRI to correctly identify the presence or absence of cancer into prostate sextants.

Trial Locations

Locations (1)

Prof O. ROUVIERE; 🇫🇷 Lyon, Rhône, France