Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT

• Conditions: Prostatic Neoplasms

• Registration Number: NCT03533998
• Lead Sponsor: Institut Mutualiste Montsouris

Brief Summary

The ability of genomic biomarkers to Measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence BCR after focal therapy or RP.

Detailed Description

Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutual Montsouris). Primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. Thirteen SRP after focal ablative therapies FAT (cryotherapy or high intensity focused ultrasound- HIFU or vascular-targeted photodynamic therapy- VTP) were identified from our prospective collected database. Genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (IHC) markers were used in the diagnosis of limited primary PC on needle biopsy when necessary. Prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. Residual disease was graded according to the Gleason grading system. Treatment-related histologic changes were examined.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-11
• Study First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23
• Study Start: 2018-05-31
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Prostate Cancer treated with salvage radical prostatectomy following failure of focal ablative therapies

Exclusion Criteria

• Primary radiotherapy, brachytherapy and whole-gland treatments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ability of genomic biomarkers to Measuring tumour aggressiveness	molecular analyses	Fragment of Paraffin specimen after RP will be used for the analyses by Biomarkers; MYC, PTEN protein loss, chromosome 8 alterations; .

Trial Locations

Locations (1)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France