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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT01020448

First received: November 24, 2009

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 24, 2009

Last Updated Date

April 23, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PCA3 score expressed as a ratio of PCA3 mRNA (messenger ribonucleic acid) over PSA (prostate specific antigen) mRNA. [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01020448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PCA3 score expressed as a ratio of PCA3 mRNA over PSA mRNA. [ Time Frame: 1 month and at 3 months post-treatment ] [ Designated as safety issue: No ]
TMPRSS2-ERG score (expressed as a ratio of T2-ERG mRNA over PSA mRNA). [ Time Frame: 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
Proportion of patients medically castrated (i.e. with serum testosterone levels of <50 ng/dL). [ Time Frame: 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
PSA level change. [ Time Frame: From baseline to 1, 3 and 6 months post-treatment ] [ Designated as safety issue: No ]
Safety, assessed through the collection of adverse events (AEs). [ Time Frame: For the duration of the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 T2- ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics according to risk factors such as PSA, Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: Triptorelin (Decapeptyl®)

One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

Study Arm (s)

Experimental: Triptorelin (Decapeptyl®) 22.5 mg

Intervention: Drug: Triptorelin (Decapeptyl®)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

339

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Romania, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01020448

Other Study ID Numbers ^ICMJE

8-79-52014-168, 2009-012786-58

Has Data Monitoring Committee

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Patrick Cabri, M.D.

Ipsen

Information Provided By

Ipsen

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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