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Casodex/Zoladex Biomarkers in Localised Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293696
First Posted: February 17, 2006
Last Update Posted: May 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Tampere
  Purpose
To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones

Condition Intervention Phase
Prostate Cancer Drug: bicalutamide (Casodex), goserelin (Zoladex) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Pilot Study to Evaluate the Effect(s) of Casodex 150 mg and Zoladex 3.6 mg on Pathological and Genomic Tumour Markers in Subjects Undergoing Radical Prostatectomy for Localised Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Proliferation by Ki67,
  • apoptosis marker (TUNEL assay),
  • Gleason score

Secondary Outcome Measures:
  • expression of known androgen-regulated genes,
  • biomarkers of apoptotic pathway,
  • (novel) genomic transcripts

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: November 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed localised prostate biopsy specimen that contains sufficient tumour for evaluation of cell proliferation and apoptosis markers
  2. Patients who are scheduled for radical prostatectomy with curative intents
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293696


Locations
Finland
TUCH
Tampere, Finland, 33521
Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Teuvo L Tammela, Professor Tampere University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00293696     History of Changes
Other Study ID Numbers: D6876C00001
First Submitted: February 16, 2006
First Posted: February 17, 2006
Last Update Posted: May 8, 2007
Last Verified: May 2007

Keywords provided by University of Tampere:
biomarker study
Patients with clinically localised prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Bicalutamide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs