GP Extended Action Triptorelin (GREAT)

Ipsen

Status and phase

Terminated

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Decapeptyl® SR 22.5mg

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01673984

2011-004213-16 (EudraCT Number)

A-97-52014-181

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.