Trials / Completed
CompletedNCT01857037
Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI
Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Histoscanning™ and multiparametric MRI | Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2013-05-20
- Last updated
- 2025-09-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01857037. Inclusion in this directory is not an endorsement.