GP Extended Action Triptorelin

NCT ID: NCT01673984

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decapeptyl® SR 22.5mg (Triptorelin)

Group Type: EXPERIMENTAL

Decapeptyl® SR 22.5mg

Intervention Type: DRUG

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

Current 3-monthly LHRH agonist

One of the following: Decapeptyl® SR 11.25mg (Triptorelin), Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

Decapeptyl® SR 22.5mg

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Triptorelin; Triptorelin

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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

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

Sherbourne Medical Centre

Royal Leamington Spa, , 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

Countries

United Kingdom

Other Identifiers

2011-004213-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A-97-52014-181

Identifier Type: -

Identifier Source: org_study_id