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OPALE: Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

Sponsor
University Hospital, Rouen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03611686
Collaborator
(none)
500
Enrollment
1
Location
95.5
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration

Condition or Disease Intervention/Treatment Phase
  • Drug: Local chemotherapy

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies
Actual Study Start Date :
Apr 17, 2018
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
patient followed for metastatic prostate adenocarcinoma

patient wil be followed for metastatic prostate adenocarcinoma during 3 years

Drug: Local chemotherapy
Local chemotherapy will be administrated according to local recommendation

Outcome Measures

Primary Outcome Measures

  1. Number of alive patient [3 years]

Secondary Outcome Measures

  1. Number of alive patient disease free [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patient monitored for castration-resistant metastatic prostate

  • Patients starting a first or second line treatment as part of castration resistance

  • Patient not objecting to the study after reading the information letter

  • Patient aged over 18 years

Exclusion Criteria:

  • Patient monitored for non-metastatic prostate cancer

  • Patient monitored for castration-nonresistant prostate cancer

  • Patient not able to understand the information letter

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rouen University Hospital Rouen France

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

  • Principal Investigator: Sophie GOUERANT, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT03611686
Other Study ID Numbers:
  • 2017/090/HP
First Posted:
Aug 2, 2018
Last Update Posted:
Nov 6, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 6, 2019