FINNPROSTATE Study VII: Intermittent Versus Continuous An... | NCT00293670

Studies
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

NCT00293670

Sponsor

Tampere University

Status

Unknown status

Last Update Posted

Feb 17, 2006Estimated

Enrollment

573

Phase

Phase 4

Conditions

Patients With T1-4 Advanced Prostate Cancer

Interventions

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

Feb 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1997

Primary Completion Date

Not provided

Completion Date

Apr 2015

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

Feb 16, 2006

Last Update Posted Date

Feb 17, 2006Estimated

Name	Class
Finnish Prostate Cancer Group	UNKNOWN

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

573

Name	Type	Description	Arm Group Labels	Other Names
Goserelin (Zoladex)	Drug

Measure	Description	Time Frame
Time To Progression (TTP)

Measure	Description	Time Frame
Overall and prostate cancer-specific survival, time to treatment failure, quality of life

Eligibility Module

Eligibility Criteria

• Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA > 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA > 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent

• Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to < 10 ng/mL. If the baseline was < 20ng/mL, at least 50% decrease from the baseline measurement is required

Exclusion Criteria (run-in period):

Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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 Central Hospital, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TUCH (Tampere University Central Hospital)		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22857983	Derived	Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects. Eur Urol. 2013 Jan;63(1):111-20. doi: 10.1016/j.eururo.2012.07.040. Epub 2012 Jul 27.
22498230

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