ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01857037
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : March 2, 2015
Sponsor:
Information provided by (Responsible Party):
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


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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Single arm
Single arm
Other: Histoscanning™ and multiparametric MRI
Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
France
Prof O. ROUVIERE
Lyon, Rhône, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Olivier Rouvière, Pr Hospices Civiles de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01857037     History of Changes
Other Study ID Numbers: 2010.655
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: March 2, 2015
Last Verified: April 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes