Back to resultsFINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Primary Purpose
Patients With T1-4 Advanced Prostate Cancer
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Goserelin (Zoladex)
Sponsored by
About this trial
This is an interventional treatment trial for Patients With T1-4 Advanced Prostate Cancer
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 -
Sites / Locations
- TUCH (Tampere University Central Hospital)
Outcomes
Primary Outcome Measures
Time To Progression (TTP)
Secondary Outcome Measures
Overall and prostate cancer-specific survival, time to treatment failure, quality of life
Full Information
NCT ID
NCT00293670
First Posted
February 16, 2006
Last Updated
February 16, 2006
Sponsor
Tampere University
Collaborators
Finnish Prostate Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT00293670
Brief Title
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Official Title
Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2015 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tampere University
Collaborators
Finnish Prostate Cancer Group
4. Oversight
5. Study Description
Brief Summary
To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With T1-4 Advanced Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
573 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Goserelin (Zoladex)
Primary Outcome Measure Information:
Title
Time To Progression (TTP)
Secondary Outcome Measure Information:
Title
Overall and prostate cancer-specific survival, time to treatment failure, quality of life
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teuvo L Tammela, Professor
Organizational Affiliation
Tampere University Central Hospital, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
TUCH (Tampere University Central Hospital)
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22857983
Citation
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.
Results Reference
derived
PubMed Identifier
22498230
Citation
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.
Results Reference
derived
Learn more about this trial
FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
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