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

February 16, 2006 updated by: Tampere University

Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

573

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • TUCH (Tampere University Central Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

• 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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time To Progression (TTP)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Collaborators

Finnish Prostate Cancer Group

Investigators

  • Principal Investigator: Teuvo L Tammela, Professor, Tampere University Central Hospital, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Completion

April 1, 2015

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2006

Last Update Submitted That Met QC Criteria

February 16, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9393FN/0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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