Casodex/Zoladex Biomarkers in Localised Prostate Cancer | NCT00293696

Studies
Casodex/Zoladex Biomarkers in Localised Prostate Cancer

NCT00293696

Sponsor

Tampere University

Status

Completed

Last Update Posted

May 8, 2007Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Prostate Cancer

Interventions

bicalutamide (Casodex), goserelin (Zoladex)

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Feb 16, 2006

First Submission Date that Met QC Criteria

Feb 16, 2006

First Posted Date

Feb 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2007

Last Update Posted Date

May 8, 2007Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
bicalutamide (Casodex), goserelin (Zoladex)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proliferation by Ki67,
apoptosis marker (TUNEL assay),
Gleason score

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teuvo L Tammela, Professor	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TUCH		Tampere		33521	Finland

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C053541	bicalutamide
D017273	Goserelin

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided