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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Triptorelin (Decapeptyl®)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triptorelin (Decapeptyl®) 22.5 mg<br> | Drug: Triptorelin (Decapeptyl®)<br>* One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA | 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 | At month 6 post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA | 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 | At month 1 and 3 post-treatment | 
| TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) | 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.' | 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 | 
| PSA Level |  | At baseline, 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced or metastatic Prostate Cancer