Prostatic Cancer Versus Androgen Deficiency

NCT ID: NCT02235142

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-03

Study Completion Date

2021-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer of Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Localised prostat cancer and androgen deficiency

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

Interventions

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Blood sample

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Saint Augustin

Bordeaux, , France

Site Status

Hôpitaux Civils de Colmar

Colmar, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

La Pitié-Salpêtrière (AP-HP)

Paris, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

Hôpital Foch

Suresnes, Île-de-France Region, France

Site Status

CHU Pointe à Pitre

Pointe-à-Pitre, , Guadeloupe

Site Status

CHU Fort de France

Fort-de-France, , Martinique

Site Status

Countries

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France Guadeloupe Martinique

References

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Pattou M, Neuzillet Y, Ghoneim T, Bosset PO, Vanalderverelt V, Bohin D, Lugagne PM, Soorojebally Y, Schneider M, Cathelineau X, Roupret M, Drouin SJ, Lebret T. Evaluating the Safety of Delaying Surgery Beyond 9 Months in Localized Prostate Cancer Patients: Results From a Prospective Study With Propensity Score Matching. Int J Urol. 2025 Sep;32(9):1243-1249. doi: 10.1111/iju.70142. Epub 2025 Jun 4.

Reference Type DERIVED
PMID: 40462596 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30293206 (View on PubMed)

Other Identifiers

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2012-A01742-41

Identifier Type: OTHER

Identifier Source: secondary_id

2013/01

Identifier Type: -

Identifier Source: org_study_id

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