We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01020448
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : July 15, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Triptorelin (Decapeptyl®) Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA [ Time Frame: At month 6 post-treatment ]

    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


Secondary Outcome Measures :
  1. PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA [ Time Frame: At month 1 and 3 post-treatment ]

    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

  2. TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA) [ Time Frame: At baseline, month 1, 3 and 6 post-treatment ]

    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.'


  3. Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL) [ Time Frame: At month 1, 3 and 6 post-treatment ]
  4. PSA Level [ Time Frame: At baseline, month 1, 3 and 6 post-treatment ]
  5. Safety, Assessed Through the Collection of Adverse Events (AEs) [ Time Frame: For the duration of the study (up to month 6) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020448


Locations
Show Show 59 study locations
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01020448    
Other Study ID Numbers: 8-79-52014-168
2009-012786-58 ( EudraCT Number )
First Posted: November 25, 2009    Key Record Dates
Results First Posted: July 15, 2015
Last Update Posted: January 30, 2019
Last Verified: January 2019
Keywords provided by Ipsen:
Locally advanced or metastatic Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents