A clinical study to access the change in the score of two biomarkers in patients who are begining treatment with androgen deprivatin therapy (Triptorelin 22.5mg) that have advanced prosate cancer.

Phase 1

• Conditions: ocally advanced or metastatic prostate cancer; MedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012786-58-BE
• Lead Sponsor: Ipsen Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 315

Inclusion Criteria

All patients must fulfil the following:
Patients must give written (personally signed and dated) informed consent before completing any study-related procedure.
Patients must be 18 years old or over.
Patient must have a histologically confirmed, locally advanced or metastatic prostate cancer, and be naive to androgen deprivation therapy, and be candidate for hormonal treatment.
Patient must have an estimated survival time of at least twelve months according to the investigator's assessment.
Patient must have a performance status score = 2 according to the WHO criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be included in the study if:
The patient with no risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy).
The patient has had previous surgical castration.
The patient has had previous or has planned curative prostate cancer therapy (radiation/surgery).
The patients has had previous hormone therapy (GnRH analogues, estrogens or anti-androgens).
The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or presents any concomitant condition which cold compromise the objectives of hte study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastasis, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
Patient who have received investigational drug or treatment within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments.
Diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin.
Known hypersensitivity to triptorelin, GnRH, other GnRH agonist analogues or analogues to an excipients of the IMP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified