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GP Extended Action Triptorelin (GREAT)

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ClinicalTrials.gov Identifier: NCT01673984
Recruitment Status : Terminated (The study was discontinued prematurely by the sponsor due to non-medical reasons)
First Posted : August 28, 2012
Results First Posted : September 29, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE August 23, 2012
First Posted Date  ICMJE August 28, 2012
Results First Submitted Date  ICMJE July 10, 2015
Results First Posted Date  ICMJE September 29, 2015
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
Percentage of Participants Maintaining Biochemical Castration [ Time Frame: 6 months ]
Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
Change from baseline in the percentage of participants who maintain biochemical castration [ Time Frame: 6 months ]
A difference of less than 7.5% between the two treatment arms is considered to be not clinically relevant.
Change History Complete list of historical versions of study NCT01673984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. [ Time Frame: 12 months ]
    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..
  • Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels [ Time Frame: 6 and 12 months ]
    Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.
  • Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire. [ Time Frame: Baseline and Month 12 ]
    The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).
  • Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II) [ Time Frame: 6 and 12 month ]
    TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.
  • Patient Satisfaction With Treatment. [ Time Frame: Month 12 ]
    Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.
  • Percentage of Participants Who Changed Injection Frequency After Completion of the Study [ Time Frame: Month 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • Change from baseline in the percentage of participants who demonstrating stable prostate-specific antigen (PSA) levels [ Time Frame: 6 and 12 months ]
  • Change from baseline in quality of life measured using EQ-5D-5L [ Time Frame: Month 12 ]
  • Patient satisfaction with medication using Treatment Satisfaction Questionnaire for Medication (TSQM version II) [ Time Frame: Baseline, month 6 and 12 ]
  • Patient satisfaction with treatment using a non-validated study-specific Likert-type scale [ Time Frame: Month 12 ]
  • The percentage of participants who remain on the same formulation of LHRH agonist as their study treatment [ Time Frame: Month 12 ]
  • Change from baseline in the percentage of participants who maintain biochemical castration [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GP Extended Action Triptorelin
Official Title  ICMJE A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG
Brief Summary The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Decapeptyl® SR 22.5mg
    22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
    Other Name: Triptorelin
  • Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
    For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
    Other Name: Triptorelin
Study Arms  ICMJE
  • Experimental: Decapeptyl® SR 22.5mg (Triptorelin)
    Intervention: Drug: Decapeptyl® SR 22.5mg
  • Active Comparator: Current 3-monthly LHRH agonist
    One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
    Intervention: Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
27
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
168
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must give written (personally signed and dated) informed consent before completing any study related procedure.
  • Patients must be 18 years old or over.
  • Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment
  • Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL
  • Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests
  • Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value).

In addition:

  • For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline,
  • For patients with metastatic prostate cancer (M+) and a Gleason score

    ≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline,

  • For patients with metastatic prostate cancer (M+) and a Gleason score > 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline.
  • Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment.

Exclusion Criteria:

  • Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
  • Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions.
  • Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
  • Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma.
  • Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy.
  • Patients scheduled to receive palliative radiotherapy during the course of the study.
  • Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy.
  • Patients receiving LHRH agonist as adjuvant to surgery.
  • Patients scheduled to undergo radical prostatectomy during the course of the study.
  • Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01673984
Other Study ID Numbers  ICMJE A-97-52014-181
2011-004213-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date January 2019

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