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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin (Decapeptyl®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01020448

2009-012786-58 (EudraCT Number)

8-79-52014-168

Details and patient eligibility

About

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.

Enrollment

339 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)