NCT00293696

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 prostate-cancer

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

May 8, 2007

Status Verified

May 1, 2007

First QC Date

February 16, 2006

Last Update Submit

May 7, 2007

Conditions

Prostate Cancer

Keywords

biomarker studyPatients with clinically localised prostate cancer

Outcome Measures

Primary Outcomes (3)

  • Proliferation by Ki67,

  • apoptosis marker (TUNEL assay),

  • Gleason score

Secondary Outcomes (3)

  • expression of known androgen-regulated genes,

  • biomarkers of apoptotic pathway,

  • (novel) genomic transcripts

Interventions

bicalutamide (Casodex), goserelin (Zoladex)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUCH

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideGoserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Teuvo L Tammela, Professor

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

October 1, 2004

Study Completion

November 1, 2006

Last Updated

May 8, 2007

Record last verified: 2007-05

Locations

FI(1)