NCT03533998

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 11, 2018

Last Update Submit

May 11, 2018

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age50 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsprostate
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between 2007 and 2017, 30 patients underwent salvage radical prostatectomy SRP for recurrent localized PCa at our institution (Institute Mutualiste Montsouris).

You may qualify if:

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

You may not qualify if:

  • Primary radiotherapy, brachytherapy and whole-gland treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE tumor tissue of radical prostatectomy.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Qusay Mandoorah, resident

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qusay Mandoorah, resident

CONTACT

33761221259mandoorah104@gmail.com

Rafael Sanchez-Salas, surgeon

CONTACT

331rafael.sanchez-salas@imm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

May 31, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

FR(1)