GP Extended Action Triptorelin

Prostate Cancer Clinical Trial

— GREAT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01673984
• Other study ID #: A-97-52014-181
• Secondary ID: 2011-004213-16
• Status: Terminated
• Phase: Phase 4
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: November 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Decapeptyl® SR 22.5mg
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 10.8mg
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

Locations

Country	Name	City	State
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 Dept., Rowden Surgery	Chippenham
United Kingdom	Clinical Research Unit, Hathaway Medical Centre	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 Common
United Kingdom	Kiltearn Medical Centre	Nantwich
United Kingdom	Danes Camp Surgery	Northampton
United Kingdom	Kingsthorpe Medical Centre	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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Maintaining Biochemical Castration	Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.	6 months
Secondary	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..	12 months
Secondary	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.	6 and 12 months
Secondary	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).	Baseline and Month 12
Secondary	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.	6 and 12 month
Secondary	Patient Satisfaction With Treatment.	Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.	Month 12
Secondary	Percentage of Participants Who Changed Injection Frequency After Completion of the Study		Month 12