Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

Prostate Cancer Clinical Trial

— HORM  

Official title:

Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03014973
• Other study ID #: 2016/03
• Secondary ID: 2016-A00020-51
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment

• group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression

• group 2a: without radiotherapy

• group 2b: with radiotherapy

• Affiliated to a social security scheme

• Having given a written consent.

Exclusion Criteria:

• Patient unable to supply a written consent (patient not understanding French, under guardianship patient).

• neuro-endocrine form or sarcomatoid form prostate cancer

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• intra-prostatic concentration of sexual steroids

Procedure:
• Trans-rectal biopsy

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-prostatic concentration of sexual steroids		2 weeks
Secondary	Androgen receptor immuno-histochemical expression level		2 weeks
Secondary	Androgen receptor RNA expression level		2 weeks
Secondary	Steroid 5-alphareductase immuno-histochemical expression level		2 weeks
Secondary	Steroid 5-alphareductase RNA expression level		2 weeks
Secondary	Steroid aromatase immuno-histochemical expression level		2 weeks
Secondary	Steroid aromatase RNA expression level		2 weeks