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Prostatic Cancer Versus Androgen Deficiency (AndroCan)

Primary Purpose

Cancer of Prostate

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer of Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Foch
  • Clinique Saint Augustin
  • Hôpitaux Civils de Colmar
  • Hôpital Henri Mondor
  • La Pitié-Salpêtrière (AP-HP)
  • Institut Mutualiste Montsouris
  • CHU Pointe à Pitre
  • CHU Fort de France

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Localised prostat cancer and androgen deficiency

Arm Description

Outcomes

Primary Outcome Measures

Testosteron Serum level
Gleason score

Secondary Outcome Measures

Full Information

First Posted
September 5, 2014
Last Updated
January 19, 2022
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02235142
Brief Title
Prostatic Cancer Versus Androgen Deficiency
Acronym
AndroCan
Official Title
Localised Cancer of Prostate and Androgen Deficiency.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2013 (Actual)
Primary Completion Date
June 27, 2016 (Actual)
Study Completion Date
December 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Prostate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Localised prostat cancer and androgen deficiency
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Testosteron Serum level
Time Frame
The day prior to surgery
Title
Gleason score
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
State/Province
Ile De France
ZIP/Postal Code
92150
Country
France
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
La Pitié-Salpêtrière (AP-HP)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Pointe à Pitre
City
Pointe-à-Pitre
ZIP/Postal Code
97110
Country
Guadeloupe
Facility Name
CHU Fort de France
City
Fort-de-France
ZIP/Postal Code
97200
Country
Martinique

12. IPD Sharing Statement

Citations:
PubMed Identifier
30293206
Citation
Neuzillet Y, Raynaud JP, Dreyfus JF, Radulescu C, Rouanne M, Schneider M, Krish S, Roupret M, Drouin SJ, Comperat E, Galiano M, Cathelineau X, Validire P, Molinie V, Fiet J, Giton F, Lebret T, Botto H. Aggressiveness of Localized Prostate Cancer: the Key Value of Testosterone Deficiency Evaluated by Both Total and Bioavailable Testosterone: AndroCan Study Results. Horm Cancer. 2019 Feb;10(1):36-44. doi: 10.1007/s12672-018-0351-8. Epub 2018 Oct 6.
Results Reference
derived

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Prostatic Cancer Versus Androgen Deficiency

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