Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin Pamoate 11.25mg
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when
      administered by subcutaneous route.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven locally advanced or metastatic prostate cancer who are suitable
             for androgen deprivation therapy

          -  Male aged ≥18 years old

          -  Screening testosterone level of >125 ng/dL

          -  Life expectancy of greater than 12 months in the judgement of the Investigator

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Willing to give signed informed consent freely

          -  Able to adhere to the study visit schedule and other protocol requirements.

        Exclusion Criteria:

          -  Prior hormonal therapy for prostate cancer

          -  Prior surgery or radiotherapy of prostate cancer with curative intent unless disease
             is verified by a rising prostate specific antigen (PSA) concentration on follow up
             (elevated PSA values on last two tests conducted at least a month apart) and the
             patient is eligible for androgen deprivation therapy

          -  Presence or history of any other malignancy except for non melanoma skin cancer
             adequately treated at least 2 years before study entry

          -  Painful local bone lesions or spinal lesions which may lead to compression

          -  History of myocardial infarction, percutaneous coronary intervention, acute coronary
             syndrome, coronary artery bypass graft, Class III/IV congestive heart failure,
             cerebrovascular accident, transient ischaemic attack, or limb claudication at rest,
             within six months prior to start of study treatment and ongoing symptomatic
             dysrhythmias, unstable angina, uncontrolled hypertension, and untreated atrial or
             uncontrolled ventricular arrhythmias

          -  Any condition in opinion of the Investigator, including other active or latent
             infections, medical or psychiatric conditions, or the presence of laboratory
             abnormalities, which could confound the ability to interpret data from the study,
             compromises the objective of the study or places the patient at unacceptable risk if
             he participates in the study

          -  Abnormal haematological, hepatic or renal functions:

               -  Haemoglobin <9 g/dL, absolute neutrophil count ≤1.5 x 10^9/L or platelets ≤100 x
                  10^9/L

               -  Serum creatinine ≥1.5 times the upper limit of normal (ULN)

               -  Aspartate aminotransferase or alanine aminotransferase >2.5 times the ULN

          -  Known hypersensitivity to the study treatment, to any of its excipients

          -  Known active use of recreational drug or alcohol dependence in the opinion of the
             Investigator

          -  Any current use or use within six months prior to start of treatment, of medications
             which are known to affect the metabolism and/or secretion of androgenic hormones: e.g.
             ketoconazole, aminoglutethimide, oestrogens, and progesterone

          -  Use of systemic corticosteroids (inhaled corticosteroids and topical application of
             corticosteroids are permitted)

          -  Aged ≥90 years for the main study and ≥80 years for those included in the
             pharmacokinetic (PK) patient population

          -  Participation in any other study or receipt of any investigational compound in the 30
             days (or five times the elimination half life if this is longer) prior to study entry

          -  Any skin or other condition that may preclude s.c. injection administration

          -  Known brain or epidural metastases.