Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI (HISTO-RAD)
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|ClinicalTrials.gov Identifier: NCT01857037|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : March 2, 2015
- 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)
- 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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrent||Other: Histoscanning™ and multiparametric MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Other: Histoscanning™ and multiparametric MRI
Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI
- Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy. [ Time Frame: 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.
- Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857037
|Prof O. ROUVIERE|
|Lyon, Rhône, France, 69437|
|Principal Investigator:||Olivier Rouvière, Pr||Hospices Civiles de Lyon|