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

Ipsen59 sites in 10 countries339 target enrollmentNovember 2009

ConditionsProstate Cancer

InterventionsTriptorelin (Decapeptyl®)

DrugsTriptorelin (Decapeptyl®)

Overview

Phase: Phase 3
Intervention: Triptorelin (Decapeptyl®)
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 339
Locations: 59
Primary Endpoint: PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

June 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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)

Arms & Interventions

Triptorelin (Decapeptyl®) 22.5 mg

Intervention: Triptorelin (Decapeptyl®)

Outcomes

Primary Outcomes

PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA

Time Frame: 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 Outcomes

PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA(At month 1 and 3 post-treatment)
TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)(At baseline, month 1, 3 and 6 post-treatment)
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))