Casodex/Zoladex Biomarkers in Localised Prostate Cancer

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293696

Enrollment

Registered

2006-02-17

Start date

2004-10-31

Completion date

2006-11-30

Last updated

2007-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

biomarker study, Patients with clinically localised prostate cancer

Brief summary

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

Interventions

DRUGbicalutamide (Casodex), goserelin (Zoladex)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proliferation by Ki67,	—
apoptosis marker (TUNEL assay),	—
Gleason score	—

Secondary

Measure	Time frame
expression of known androgen-regulated genes,	—
biomarkers of apoptotic pathway,	—
(novel) genomic transcripts	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026