Back to resultsCasodex/Zoladex Biomarkers in Localised Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
bicalutamide (Casodex), goserelin (Zoladex)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring biomarker study, Patients with clinically localised prostate cancer
Eligibility 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
Sites / Locations
- TUCH
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00293696
Brief Title
Casodex/Zoladex Biomarkers in Localised Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tampere University
4. Oversight
5. Study Description
Brief Summary
To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
biomarker study, Patients with clinically localised prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bicalutamide (Casodex), goserelin (Zoladex)
Primary Outcome Measure Information:
Title
Proliferation by Ki67,
Title
apoptosis marker (TUNEL assay),
Title
Gleason score
Secondary Outcome Measure Information:
Title
expression of known androgen-regulated genes,
Title
biomarkers of apoptotic pathway,
Title
(novel) genomic transcripts
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teuvo L Tammela, Professor
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
TUCH
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Casodex/Zoladex Biomarkers in Localised Prostate Cancer
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