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Casodex/Zoladex Biomarkers in Localised Prostate Cancer

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. Identifier: NCT00293696
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : May 8, 2007
Information provided by:
Tampere University

Brief Summary:
To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bicalutamide (Casodex), goserelin (Zoladex) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : October 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Proliferation by Ki67,
  2. apoptosis marker (TUNEL assay),
  3. Gleason score

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00293696

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Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University
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Principal Investigator: Teuvo L Tammela, Professor Tampere University Hospital
Layout table for additonal information Identifier: NCT00293696    
Other Study ID Numbers: D6876C00001
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: May 8, 2007
Last Verified: May 2007
Keywords provided by Tampere University:
biomarker study
Patients with clinically localised prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs