NCT01191099

Brief Summary

A single-center cohort study to identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

August 25, 2010

Last Update Submit

November 7, 2011

Conditions

Prostate Cancer

Interventions

PimonidazolDEVICE

0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy

Also known as: Hypoxyprobe

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich

You may qualify if:

  • Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich
  • Written informed consent

You may not qualify if:

  • Metastatic prostate cancer
  • Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product
  • Severe heart or lung disease
  • Severe liver or kidney dysfunction
  • Severe stridor
  • Distant metastases
  • Concurrent treatment for other malignant disease
  • Prior hormonal therapy or radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

prostate

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

  • Michael Müntener, MD

    University Hospital Zurich, Division of urology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

01 Studienregister MasterAdmins

CONTACT

+41 (0)44 255 11 11

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 30, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2020

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

CH(1)