Casodex/Zoladex Biomarkers in Localised Prostate Cancer

This study has been completed.

First Received: February 16, 2006 Last Updated: May 7, 2007 History of Changes

Sponsored by:	University of Tampere
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00293696

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 IV

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study
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

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:

Histologically confirmed localised prostate biopsy specimen that contains sufficient tumour for evaluation of cell proliferation and apoptosis markers
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

Study ID Numbers:	D6876C00001
Study First Received:	February 16, 2006
Last Updated:	May 7, 2007
ClinicalTrials.gov Identifier:	NCT00293696 History of Changes
Health Authority:	Finland: National Agency for Medicines

Keywords provided by University of Tampere:

biomarker study
Patients with clinically localised prostate cancer

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms

Genital Diseases, Male
Hormones
Carcinoma
Androgen Antagonists
Bicalutamide
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms

Genital Diseases, Male
Pharmacologic Actions
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009