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Testosterone based dosing regimen of goserelin in patients with prostate cancer

Phase 4
Completed
Conditions
Prostate cancer
prostate tumour
10038588
10036958
Registration Number
NL-OMON54398
Lead Sponsor
Franciscus Gasthuis & Vlietland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

- Informed consent
- >= 18 years
- Diagnosed with prostate cancer with an indication for Androgen Deprivation
Therapy (>= 2 years or permanently)

Exclusion Criteria

- Patients with a history of hypersensitivity to LHRH agonists
- Patients not able to visit hospital*s laboratory for blood sampling
- Patients with a serum testosterone > 1.2 nmol/L while treated with LHRH
therapy (patients who fail on LHRH therapy, in the first half year of treatment)
- Concurrent systemic anti- cancertherapy other than goserelin

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint of this study is the percentage (%) of patients for whom<br /><br>the dosing interval before the fourth goserelin 10.8<br /><br>mg injection can safely be extended with 4 weeks using a testosterone based<br /><br>dosing regimen. </p><br>
Secondary Outcome Measures
NameTimeMethod
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