Prostatic Cancer Versus Androgen Deficiency | NCT02235142

Studies
Prostatic Cancer Versus Androgen Deficiency

NCT02235142

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Jan 20, 2022Actual

Enrollment

1,614Actual

Phase

Not Applicable

Conditions

Cancer of Prostate

Interventions

Blood sample

Countries

France
Guadeloupe
Martinique

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A01742-41	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2013Actual

Primary Completion Date

Jun 27, 2016Actual

Completion Date

Dec 22, 2021Actual

First Submitted Date

Sep 5, 2014

First Submission Date that Met QC Criteria

Sep 5, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2022

Last Update Posted Date

Jan 20, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,614Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Localised prostat cancer and androgen deficiency	Experimental		Other: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other		Localised prostat cancer and androgen deficiency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Testosteron Serum level		The day prior to surgery
Gleason score		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint Augustin		Bordeaux		33000	France
Hôpitaux Civils de Colmar

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40462596	Derived	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.
30293206

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis