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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

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients demonstrating castration

Outcome Description:

The proportion of patients castrated at Day 29 and proportion of patients with castration maintained at Day 183.

Outcome Time Frame:

Days 29 and 183

Safety Issue:


Principal Investigator

Medical Director, Uro-Oncology

Investigator Role:

Study Director

Investigator Affiliation:



France: Agence Nationale de Surveillance du Medicament (ANSM)

Study ID:




Start Date:

January 2013

Completion Date:

January 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms