Phase 3
N=339
Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01020448 ↗Enrolled (actual)
339
Serious AEs
11.4%
Results posted
Jul 2015
Primary outcome: Primary: PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA — 232; 27; 10; 24 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Triptorelin (Decapeptyl®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ipsen
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA |
232; 27; 10; 24; 5 | — |
| SECONDARY PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA |
109; 40; 80; 91; 2; 215 | — |
| SECONDARY TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) |
33; 140; 149; 117; 97; 106 | — |
| SECONDARY Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) |
94.7; 95.2; 90.9 | — |
| SECONDARY PSA Level |
45.4; 8.3; 1.8; 1.2 | — |
| SECONDARY Safety, Assessed Through the Collection of Adverse Events (AEs) |
193; 190; 11; 11; 37 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment.
- An estimated survival time of at least twelve months according to the investigator's assessment.
- A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.
Exclusion Criteria
- Previous surgical castration.
- Previous or has planned curative prostate cancer therapy (radiation/surgery)
- Previous hormone therapy (GnRH analogues, estrogens or anti-androgens)
- Patients with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy)
Data sourced from ClinicalTrials.gov (NCT01020448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.