GP Extended Action Triptorelin
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Decapeptyl® SR 22.5mg; Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg
Intervention description: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).; 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 MeSH terms: Triptorelin Pamoate; Goserelin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.