GP Extended Action Triptorelin (GREAT)

May 13, 2025 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Triptorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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..
12 months
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.
6 and 12 months
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).
Baseline and Month 12
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.
6 and 12 month
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.
Month 12
Percentage of Participants Who Changed Injection Frequency After Completion of the Study
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (Estimated)

August 28, 2012

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-97-52014-181
  • 2011-004213-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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