AndroCan: Prostatic Cancer Versus Androgen Deficiency
Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT02235142
Collaborator
(none)
1,614
8
1
102.6
201.8
2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1614 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Localised Cancer of Prostate and Androgen Deficiency.
Actual Study Start Date
:
Jun 3, 2013
Actual Primary Completion Date
:
Jun 27, 2016
Actual Study Completion Date
:
Dec 22, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Localised prostat cancer and androgen deficiency
|
Other: Blood sample
|
Outcome Measures
Primary Outcome Measures
- Testosteron Serum level [The day prior to surgery]
- Gleason score [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Foch | Suresnes | Ile De France | France | 92150 |
| 2 | Clinique Saint Augustin | Bordeaux | France | 33000 | |
| 3 | Hôpitaux Civils de Colmar | Colmar | France | 68000 | |
| 4 | Hôpital Henri Mondor | Créteil | France | 94000 | |
| 5 | La Pitié-Salpêtrière (AP-HP) | Paris | France | 75013 | |
| 6 | Institut Mutualiste Montsouris | Paris | France | 75014 | |
| 7 | CHU Pointe à Pitre | Pointe-à-Pitre | Guadeloupe | 97110 | |
| 8 | CHU Fort de France | Fort-de-France | Martinique | 97200 |
Sponsors and Collaborators
- Hopital Foch
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT02235142
Other Study ID Numbers:
- 2013/01
- 2012-A01742-41
First Posted:
Sep 9, 2014
Last Update Posted:
Jan 20, 2022
Last Verified:
Jan 1, 2022
Additional relevant MeSH terms: