Text Size

Casodex/Zoladex Biomarkers in Localised Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00293696
First received: February 16, 2006
Last updated: May 7, 2007
Last verified: May 2007
History of Changes
  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
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293696

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

No publications provided

ClinicalTrials.gov 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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Bicalutamide
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013