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NCT02235142 Clinical Trial

Prostatic Cancer Versus Androgen Deficiency

Cancer of Prostate Clinical Trial

— AndroCan  

Official title:
Localised Cancer of Prostate and Androgen Deficiency.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02235142
Other study ID # 2013/01
Secondary ID 2012-A01742-41
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2013
Est. completion date December 22, 2021

Study information
Verified date January 2022
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1614
Est. completion date December 22, 2021
Est. primary completion date June 27, 2016
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample

Locations
Country Name City State
France Clinique Saint Augustin Bordeaux
France Hôpitaux Civils de Colmar Colmar
France Hôpital Henri Mondor Créteil
France Institut Mutualiste Montsouris Paris
France La Pitié-Salpêtrière (AP-HP) Paris
France Hôpital Foch Suresnes Ile De France
Guadeloupe CHU Pointe à Pitre Pointe-à-Pitre
Martinique CHU Fort de France Fort-de-France

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Countries where clinical trial is conducted

France,  Guadeloupe,  Martinique, 

Outcome
Type Measure Description Time frame Safety issue
Primary Testosteron Serum level The day prior to surgery
Primary Gleason score 5 years
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