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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

GP Extended Action Triptorelin

Short name GREAT

NCTNCT01673984 (opens ClinicalTrials.gov in a new tab)Other idA-97-52014-181Other id2011-004213-16

Overview

Status
Terminated
Phase
Phase 4
Enrollment
27 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Aug 2012
Primary completion
Feb 2014
Completion
Feb 2014
First posted
28 Aug 2012 (estimated)
Last update posted
23 May 2025
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 4

    GREAT

    NCT01673984

    Aug 2012 to Feb 2014

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Decapeptyl® SR 22.5mgDrug
  • Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mgDrug

Arms2

  • Experimental

    Decapeptyl® SR 22.5mg (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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants Maintaining Biochemical Castration

    Time frame · 6 months

    Registry description

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

Secondary outcomes(6)
  1. Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.

    Time frame · 12 months

    Registry description

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

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

    Time frame · 6 and 12 months

    Registry description

    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.

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

    Time frame · Baseline and Month 12

    Registry description

    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).

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

    Time frame · 6 and 12 month

    Registry description

    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.

  5. Patient Satisfaction With Treatment.

    Time frame · Month 12

    Registry description

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

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

    Time frame · Month 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Percentage of Participants Maintaining Biochemical Castration

GroupValue (percentage of participants)
Decapeptyl® SR 22.5mg92.9
Current 3-monthly LHRH Agonist100
Secondary and other outcome results(6)
Secondary outcomeNumber· 12 months

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

GroupValue (percentage of participants)
Decapeptyl® SR 22.5mg22.2
Current 3-monthly LHRH Agonist25.0
Secondary outcomeNumber· 6 and 12 months

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

GroupValue (percentage of participants)
Decapeptyl® SR 22.5mg84.6
Current 3-monthly LHRH Agonist100
Secondary outcomeMean· Baseline and Month 12

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

GroupValue (units on a scale)
Decapeptyl® SR 22.5mg71.7
Current 3-monthly LHRH Agonist70.0
Secondary outcomeMean· 6 and 12 month

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

GroupValue (units on a scale)
Decapeptyl® SR 22.5mg3.2
Current 3-monthly LHRH Agonist13.1
Secondary outcome· Month 12

Patient Satisfaction With Treatment.

GroupValue
Decapeptyl® SR 22.5mgnot posted
Current 3-monthly LHRH Agonistnot posted
Secondary outcomeNumber· Month 12

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

GroupValue (percentage of participants)
Decapeptyl® SR 22.5mg80
Current 3-monthly LHRH Agonist0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Decapeptyl® SR 22.5mgDecapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 \& month 6 (+/- 7 days).–2 / 1412 / 14
Current 3-monthly LHRH AgonistOne of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg 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–0 / 77 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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