Effect of Triptorelin (Decapeptyl®) 22.5 mg on Two Biomarkers in Patients With Advanced Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Triptorelin (Decapeptyl®)

• Registration Number: NCT01020448
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Primary Completion: 2011-11
• Study Completion: 2013-06
• Results First Submitted: 2015-04-30
• Results First Submitted QC: 2015-06-17
• Results First Posted: 2015-07-15
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 339

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptorelin (Decapeptyl®) 22.5 mg	Triptorelin (Decapeptyl®)	-

Primary Outcome Measures

Name	Time	Method
PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA	At month 6 post-treatment	PCA-3 score = (mRNA PCA3/mRNA PSA)x1000; * Non-assessable = Associated PSA mRNA \<7500 copies/mL; * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL; * \<35 = PCA-3 mRNA above BLQ and less than 35; * ≥35 = PCA-3 mRNA greater or equal to 35

Secondary Outcome Measures

Name	Time	Method
PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA	At month 1 and 3 post-treatment	PCA-3 score = (mRNA PCA3/mRNA PSA)x1000; * Non-assessable = Associated PSA mRNA \<7500 copies/mL; * ≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA \>7500 copies/mL; * \<35 = PCA-3 mRNA above BLQ and less than 35; * ≥35 = PCA-3 mRNA greater or equal to 35
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)	At baseline, month 1, 3 and 6 post-treatment	TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000; A TMPRSS2-ERG score \<35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'
PSA Level	At baseline, month 1, 3 and 6 post-treatment
Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)	At month 1, 3 and 6 post-treatment
Safety, Assessed Through the Collection of Adverse Events (AEs)	For the duration of the study (up to month 6)

Trial Locations

Locations (59)

Hôpital Erasme; 🇧🇪 Brussels, Belgium

UZ Brussels; 🇧🇪 Brussels, Belgium

UCL Saint-Luc; 🇧🇪 Brussels, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

CHU de Liège; 🇧🇪 Liège, Belgium

Fredericia Sygehus; 🇩🇰 Fredericia, Denmark

Frederiksbergs Hospital; 🇩🇰 Frederiksberg, Denmark

Herlev University Hospital; 🇩🇰 Herlev, Denmark

Odense Universitets hospital; 🇩🇰 Odense, Denmark

Scroll for more (49 remaining)