- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235142
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
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
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Bordeaux, France, 33000
- Clinique Saint Augustin
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Colmar, France, 68000
- Hopitaux Civils de Colmar
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Créteil, France, 94000
- Hopital Henri Mondor
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Paris, France, 75014
- Institut Mutualiste Montsouris
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Paris, France, 75013
- La Pitié-Salpêtrière (AP-HP)
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Ile De France
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Suresnes, Ile De France, France, 92150
- Hôpital Foch
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Pointe-à-Pitre, Guadeloupe, 97110
- CHU Pointe à pitre
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Fort-de-France, Martinique, 97200
- CHU Fort de France
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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 |
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Experimental: Localised prostat cancer and androgen deficiency
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Testosteron Serum level
Time Frame: The day prior to surgery
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The day prior to surgery
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Gleason score
Time Frame: 5 years
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5 years
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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
Additional Relevant MeSH Terms
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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