Trial Information
Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.
Outcome Description:
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.
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
Olivier Rouvière, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civiles de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2010.655
NCT ID:
NCT01857037
Start Date:
May 2011
Completion Date:
Related Keywords:
- Prostate Cancer Recurrent
- Prostatic Neoplasms
- Recurrence