NCT02235142

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,614

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2016

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

September 5, 2014

Last Update Submit

January 19, 2022

Conditions

Cancer of Prostate

Outcome Measures

Primary Outcomes (2)

  • Testosteron Serum level

    The day prior to surgery

  • Gleason score

    5 years

Study Arms (1)

Localised prostat cancer and androgen deficiency

EXPERIMENTAL
Other: Blood sample

Interventions

Blood sampleOTHER
Localised prostat cancer and androgen deficiency

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Hôpitaux Civils de Colmar

Colmar, 68000, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

La Pitié-Salpêtrière (AP-HP)

Paris, 75013, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Foch

Suresnes, Île-de-France Region, 92150, France

Location

CHU Pointe à Pitre

Pointe-à-Pitre, 97110, Guadeloupe

Location

CHU Fort de France

Fort-de-France, 97200, Martinique

Location

Related Publications (2)

  • 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.

    PMID: 40462596DERIVED

  • 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.

    PMID: 30293206DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

June 3, 2013

Primary Completion

June 27, 2016

Study Completion

December 22, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

FR(6)MA(1)GU(1)