Casodex/Zoladex Biomarkers in Localised Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293696
• Other study ID #: D6876C00001
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2006
• Last updated: May 7, 2007
• Start date: October 2004
• Est. completion date: November 2006

Study information

• Verified date: May 2007
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide (Casodex), goserelin (Zoladex)

Locations

Country	Name	City	State
Finland	TUCH	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proliferation by Ki67,
Primary	apoptosis marker (TUNEL assay),
Primary	Gleason score
Secondary	expression of known androgen-regulated genes,
Secondary	biomarkers of apoptotic pathway,
Secondary	(novel) genomic transcripts