Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Casodex/Zoladex Biomarkers in Localised Prostate Cancer

This study has been completed.
Information provided by:
University of Tampere Identifier:
First received: February 16, 2006
Last updated: May 7, 2007
Last verified: May 2007
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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00293696

Tampere, Finland, 33521
Sponsors and Collaborators
University of Tampere
Principal Investigator: Teuvo L Tammela, Professor Tampere University Hospital
  More Information Identifier: NCT00293696     History of Changes
Other Study ID Numbers: D6876C00001 
Study First Received: February 16, 2006
Last Updated: May 7, 2007
Health Authority: Finland: Finnish Medicines Agency

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
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Hormonal processed this record on October 25, 2016