Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer

A Phase III Single Arm Study to Evaluate the Efficacy, Safety and Local Tolerability of a Subcutaneous 3-month Formulation of Triptorelin Pamoate (11.25 mg) in Patients With Locally Advanced or Metastatic Prostate Cancer

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

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.