NCT03014973

Brief 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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

December 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 30, 2016

Last Update Submit

September 12, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • intra-prostatic concentration of sexual steroids

    2 weeks

Secondary Outcomes (6)

  • Androgen receptor immuno-histochemical expression level

    2 weeks

  • Androgen receptor RNA expression level

    2 weeks

  • Steroid 5-alphareductase immuno-histochemical expression level

    2 weeks

  • Steroid 5-alphareductase RNA expression level

    2 weeks

  • Steroid aromatase immuno-histochemical expression level

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

prostate cancer patients resistant to castration

EXPERIMENTAL
Biological: intra-prostatic concentration of sexual steroidsProcedure: Trans-rectal biopsy

patients naif of hormonal treatment

EXPERIMENTAL
Biological: intra-prostatic concentration of sexual steroidsProcedure: Trans-rectal biopsy

Interventions

intra-prostatic concentration of sexual steroidsBIOLOGICAL
patients naif of hormonal treatmentprostate cancer patients resistant to castration
Trans-rectal biopsyPROCEDURE
patients naif of hormonal treatmentprostate cancer patients resistant to castration

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
  • neuro-endocrine form or sarcomatoid form prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yann NEUZILLET, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

  • Henry Botto, MD

    Hopital Foch

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

September 13, 2018

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)