GP Extended Action Triptorelin (GREAT)

This study has been terminated.
(The study was discontinued prematurely by the sponsor due to non-medical reasons)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01673984
First received: August 23, 2012
Last updated: August 28, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention Phase
Prostate Cancer
Drug: Decapeptyl® SR 22.5mg
Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Percentage of Participants Maintaining Biochemical Castration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.


Secondary Outcome Measures:
  • Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decapeptyl® SR 22.5mg (Triptorelin) Drug: Decapeptyl® SR 22.5mg
22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
Other Name: Triptorelin
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673984

Locations
United Kingdom
The Crouch Oak Family Practice
Addlestone, United Kingdom
Dr Carter & Partners
Ashford, United Kingdom
Westongrove Research Centre, Aston Clinton Surgery
Aylesbury, United Kingdom
Clinical Research Unit, Oldfield Surgery
Bath, United Kingdom
Clinical Research Unit, The Pulteney Practice
Bath, United Kingdom
St James' Surgery
Bath, United Kingdom
Waterloo Medical Centre
Blackpool, United Kingdom
Woolpit Health Centre
Bury St. Edmunds, United Kingdom
Cossington House Surgery
Canterbury, United Kingdom
Research Office, Avondale Surgery
Chesterfield, United Kingdom
Clinical Research Dept., Rowden Surgery
Chippenham, United Kingdom
Clinical Research Unit, Hathaway Medical Centre
Chippenham, United Kingdom
The Porch Surgery
Corsham, United Kingdom
Pound Hill Surgery
Crawley, United Kingdom
The Medical Centre
East Horsley, United Kingdom
Burbage Surgery
Hinckley, United Kingdom
The Portmill Surgery
Hitchin, United Kingdom
Townhead Surgery
Irvine, United Kingdom
Sherbourne Medical Centre
Leamington Spa, United Kingdom
Mortimer Surgery
Mortimer, United Kingdom
Kiltearn Medical Centre
Nantwich, United Kingdom
Danes Camp Surgery
Northampton, United Kingdom
Kingsthorpe Medical Centre
Northampton, United Kingdom
Cape Cornwall Surgery
Penzance, United Kingdom
The Alverton Practice
Penzance, United Kingdom
Wansford & Kings Cliffe Practice, Wansford Surgery
Peterborough, United Kingdom
Knowle House Surgery
Plymouth, United Kingdom
The Rame Group Practice
Plymouth, United Kingdom
Ashfields Primary Care Centre
Sandbach, United Kingdom
Brannel Surgery
St Austell, United Kingdom
Sunbury Health Centre Group Practice
Sunbury-on-Thames, United Kingdom
Adcroft Surgery
Trowbridge, United Kingdom
Sheepcot Medical Centre
Watford, United Kingdom
Albany House Medical Centre
Wellingborough, United Kingdom
Woosehill Medical Centre
Wokingham, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Anne Fairey, M.D. Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01673984     History of Changes
Other Study ID Numbers: A-97-52014-181  2011-004213-16 
Study First Received: August 23, 2012
Results First Received: July 10, 2015
Last Updated: August 28, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Goserelin
Leuprolide
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on August 24, 2016