Biomarkers in Prostate Cancer Treated With SRP Following Failure of FAT

Prostatic Neoplasms Clinical Trial

Official title:

Biomarkers in Prostate Cancer Treated With Salvage Radical Prostatectomy Following Failure of Focal Ablative Therapies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03533998
• Other study ID #: URO-04-2018
• Status: Not yet recruiting
• Start date: May 31, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2018
• Source: Institut Mutualiste Montsouris
• Contact: Qusay Mandoorah, resident
• Phone: 33761221259
• Email: mandoorah104[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Primary radiotherapy, brachytherapy and whole-gland treatments

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ability of genomic biomarkers to Measuring tumour aggressiveness	Fragment of Paraffin specimen after RP will be used for the analyses by Biomarkers; MYC, PTEN protein loss, chromosome 8 alterations	molecular analyses