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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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