NCT00293670

Brief Summary

To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
573

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 1997

Completed
8.8 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
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 17, 2006

Status Verified

February 1, 2006

First QC Date

February 16, 2006

Last Update Submit

February 16, 2006

Conditions

Patients With T1-4 Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Time To Progression (TTP)

Secondary Outcomes (1)

  • Overall and prostate cancer-specific survival, time to treatment failure, quality of life

Interventions

Goserelin (Zoladex)DRUG

Eligibility Criteria

Age0 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUCH (Tampere University Central Hospital)

Tampere, 33521, Finland

Location

Related Publications (2)

  • 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.

    PMID: 22857983DERIVED

  • Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. The FinnProstate Study VII: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer. J Urol. 2012 Jun;187(6):2074-81. doi: 10.1016/j.juro.2012.01.122. Epub 2012 Apr 11.

    PMID: 22498230DERIVED

MeSH Terms

Interventions

Goserelin

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 Central Hospital, Finland

    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

May 1, 1997

Study Completion

April 1, 2015

Last Updated

February 17, 2006

Record last verified: 2006-02

Locations

FI(1)