Prostatic Cancer Versus Androgen Deficiency (AndroCan)

January 19, 2022 updated by: Hopital Foch

Localised Cancer of Prostate and Androgen Deficiency.

Open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. The purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1614

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33000
        • Clinique Saint Augustin
      • Colmar, France, 68000
        • Hopitaux Civils de Colmar
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75013
        • La Pitié-Salpêtrière (AP-HP)
    • Ile De France
      • Suresnes, Ile De France, France, 92150
        • Hôpital Foch
      • Pointe-à-Pitre, Guadeloupe, 97110
        • CHU Pointe à pitre
      • Fort-de-France, Martinique, 97200
        • CHU Fort de France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients over than 18 years of age, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,…) or hormonal therapy, showing indication of radical prostatectomy.

Exclusion Criteria:

  • Absence of radical prostatectomy indication
  • Patient received local or hormonal therapy prior to surgery
  • Patients already enrolled in other clinical study incompatible with the study
  • Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Localised prostat cancer and androgen deficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Testosteron Serum level
Time Frame: The day prior to surgery
The day prior to surgery
Gleason score
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2013

Primary Completion (Actual)

June 27, 2016

Study Completion (Actual)

December 22, 2021

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/01
  • 2012-A01742-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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