GP Extended Action Triptorelin (GREAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01673984
First received: August 23, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to demonstrate that treatment with a new recently launched 6-monthly injection of hormone therapy is as good and as safe 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:
  • Change from baseline in the percentage of participants who maintain biochemical castration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A difference of less than 7.5% between the two treatment arms is considered to be not clinically relevant.


Secondary Outcome Measures:
  • Change from baseline in the percentage of participants who demonstrating stable prostate-specific antigen (PSA) levels [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in quality of life measured using EQ-5D-5L [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Patient satisfaction with medication using Treatment Satisfaction Questionnaire for Medication (TSQM version II) [ Time Frame: Baseline, month 6 and 12 ] [ Designated as safety issue: No ]
  • Patient satisfaction with treatment using a non-validated study-specific Likert-type scale [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • The percentage of participants who remain on the same formulation of LHRH agonist as their study treatment [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change from baseline in the percentage of participants who maintain biochemical castration [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decapeptyl® SR 22.5mg Drug: Decapeptyl® SR 22.5mg
22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
Active Comparator: Current 3-montly LHRH agonist
One of the following: Decapeptyl® SR 11.25mg, 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

  Eligibility

Ages Eligible for Study:   18 Years and older
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 will not be included in the study if:
  • Patients have had previous surgical castration.
  • 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.
  • 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
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 Unit, Hathaway Medical Centre
Chippenham, United Kingdom
Clinical Research Dept., Rowden Surgery
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
Kingsthorpe Medical Centre
Northampton, United Kingdom
Danes Camp Surgery
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

No publications provided

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
Last Updated: February 6, 2014
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
Goserelin
Triptorelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014