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

Ipsen35 sites in 1 country27 target enrollmentAugust 2012

ConditionsProstate Cancer

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

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

Overview

Phase: Phase 4
Intervention: Decapeptyl® SR 22.5mg
Conditions: Prostate Cancer
Sponsor: Ipsen
Enrollment: 27
Locations: 35
Primary Endpoint: Percentage of Participants Maintaining Biochemical Castration
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

February 2014

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

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,

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.

Arms & Interventions

Decapeptyl® SR 22.5mg (Triptorelin)

Intervention: Decapeptyl® SR 22.5mg

Current 3-monthly LHRH agonist

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

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

Outcomes

Primary Outcomes

Percentage of Participants Maintaining Biochemical Castration

Time Frame: 6 months

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

Secondary Outcomes

Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.(Baseline and Month 12)
Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)(6 and 12 month)
Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.(12 months)
Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels(6 and 12 months)
Percentage of Participants Who Changed Injection Frequency After Completion of the Study(Month 12)
Patient Satisfaction With Treatment.(Month 12)