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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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Triptorelin (Decapeptyl®)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 339
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triptorelin (Decapeptyl®) 22.5 mg Drug: Triptorelin (Decapeptyl®)
One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020448

  Show 59 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Patrick Cabri, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01020448     History of Changes
Other Study ID Numbers: 8-79-52014-168, 2009-012786-58
Study First Received: November 24, 2009
Last Updated: April 23, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Romania: National Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ipsen:
Locally advanced or metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013