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Trial record 38 of 1543 for:    Androgens

Prostatic Cancer Versus Androgen Deficiency (AndroCan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235142
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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
Cancer of Prostate Other: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1614 participants
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 : June 3, 2013
Actual Primary Completion Date : June 27, 2016
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Localised prostat cancer and androgen deficiency Other: Blood sample



Primary Outcome Measures :
  1. Testosteron Serum level [ Time Frame: The day prior to surgery ]
  2. Gleason score [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235142


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02235142     History of Changes
Other Study ID Numbers: 2013/01
2012-A01742-41 ( Other Identifier: ANSM )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs