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Prostate CancerPhase 4GREATNCT01673984

GP Extended Action Triptorelin

A Phase 4 study testing Decapeptyl® SR 22.5mg and Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg in people with Prostate Cancer, run by Ipsen at 35 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Decapeptyl® SR 22.5mg and Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
35 sitesUnited Kingdom
Study dates
Aug 2012to Feb 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United Kingdom35 sites

  • The Crouch Oak Family Practice

    Addlestone

  • Dr Carter & Partners

    Ashford

  • Westongrove Research Centre, Aston Clinton Surgery

    Aylesbury

  • Clinical Research Unit, Oldfield Surgery

    Bath

  • Clinical Research Unit, The Pulteney Practice

    Bath

  • St James' Surgery

    Bath

  • Waterloo Medical Centre

    Blackpool

  • Woolpit Health Centre

    Bury St Edmunds

  • Cossington House Surgery

    Canterbury

  • Research Office, Avondale Surgery

    Chesterfield

  • Clinical Research Dept., Rowden Surgery

    Chippenham

  • Clinical Research Unit, Hathaway Medical Centre

    Chippenham

  • The Porch Surgery

    Corsham

  • Pound Hill Surgery

    Crawley

  • The Medical Centre

    East Horsley

  • Burbage Surgery

    Hinckley

  • The Portmill Surgery

    Hitchin

  • Townhead Surgery

    Irvine

  • Mortimer Surgery

    Mortimer Common

  • Kiltearn Medical Centre

    Nantwich

  • Danes Camp Surgery

    Northampton

  • Kingsthorpe Medical Centre

    Northampton

  • Cape Cornwall Surgery

    Penzance

  • The Alverton Practice

    Penzance

  • Wansford & Kings Cliffe Practice, Wansford Surgery

    Peterborough

  • Knowle House Surgery

    Plymouth

  • The Rame Group Practice

    Plymouth

  • Sherbourne Medical Centre

    Royal Leamington Spa

  • Ashfields Primary Care Centre

    Sandbach

  • Brannel Surgery

    St Austell

  • Sunbury Health Centre Group Practice

    Sunbury-on-Thames

  • Adcroft Surgery

    Trowbridge

  • Sheepcot Medical Centre

    Watford

  • Albany House Medical Centre

    Wellingborough

  • Woosehill Medical Centre

    Wokingham

Other trials in United Kingdom

About this study

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

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.

Conditions
Prostate Cancer
Being tested
Decapeptyl® SR 22.5mg, Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decapeptyl® SR 22.5mgDrug

    Also called Triptorelin

    22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).

  • Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mgDrug

    Also called Triptorelin

    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

Study groups in NCT01673984
Study groupRoleWhat they receive
Decapeptyl® SR 22.5mg (Triptorelin)ExperimentalNot described
Receives: Drug: Decapeptyl® SR 22.5mg
Current 3-monthly LHRH agonistActive comparatorOne of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg
Receives: Drug: Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Maintaining Biochemical Castration

    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.

    Measured: 6 months

Secondary outcomes (6)

  1. Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.

    Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..

    Measured: 12 months

  2. Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels

    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.

    Measured: 6 and 12 months

  3. Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.

    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).

    Measured: Baseline and Month 12

  4. Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)

    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.

    Measured: 6 and 12 month

  5. Patient Satisfaction With Treatment.

    Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.

    Measured: Month 12

  6. Percentage of Participants Who Changed Injection Frequency After Completion of the Study

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: The study was discontinued prematurely by the sponsor due to non-medical reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673984
Sponsor's protocol ID
A-97-52014-181
Other IDs
2011-004213-16
Acronym
GREAT
Status last verified
May 2025
First submitted
23 Aug 2012
Last updated
23 May 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Decapeptyl® SR 22.5mg and Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg in people with Prostate Cancer, run by Ipsen at 35 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Maintaining Biochemical Castration (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01673984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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