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

Study Overview
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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

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

Conditions
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Prostate Cancer Recurrent

Intervention / Treatment
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* Other: Histoscanning™ and multiparametric MRI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Single arm | Other: Histoscanning™ and multiparametric MRI<br>* Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy. | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy. | 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. | 1 day |