Trials / Completed
CompletedNCT01020448
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 339 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triptorelin (Decapeptyl®) | One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed. |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-11-01
- Completion
- 2013-06-01
- First posted
- 2009-11-25
- Last updated
- 2019-01-30
- Results posted
- 2015-07-15
Locations
59 sites across 10 countries: Belgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Romania, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01020448. Inclusion in this directory is not an endorsement.