Locally advanced or metastatic prostate cancer MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Decapeptyl 3-month, 11.25mg
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: TRIPTORELIN PAMOATE
Other descriptive name: 3 month formulation of tr
Sponsors
Ipsen Pharma S.A.S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: . Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy 2. Male aged =18 years old 3. Screening testosterone level of >125 ng/dL 4. Life expectancy of greater than 12 months in the judgement of the Investigator 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 6. Willing to give signed informed consent freely 7. Able to adhere to the study visit schedule and other protocol requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: 1. Prior hormonal therapy for prostate cancer 2. Prior surgery or radiotherapy of prostate cancer with curative intent unless disease is verified by a rising 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 3. Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry 4. Painful local bone lesions or spinal lesions which may lead to compression 5. 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 6. 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 7. Abnormal haematological, hepatic or renal functions: • Haemoglobin 2.5 times the ULN 8. Known hypersensitivity to the study treatment, to any of its excipients 9. Known active use of recreational drug or alcohol dependence in the opinion of the Investigator 10. 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 11. Use of systemic corticosteroids (inhaled corticosteroids and topical application of corticosteroids are permitted) 12. Aged =90 years for the main study and =80 years for those included in the PK population 13. 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 14. Any skin or other condition that may preclude s.c. injection administration 15. Known brain or epidural metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To assess the proportion of patients demonstrating castration at Day 92 (before administration of the second dose) • To demonstrate the ability of triptorelin to suppress the acute-on-chronic effect following administration of the second dose, by assessing the proportion of patients castrated, 3-4 days after the second injection (Day 95) • To assess time to castration • To assess the residual triptorelin levels in all patients at Days 92 and 183 (i.e. at 13 weeks following each s.c. administration) • To assess the effect of triptorelin on prostate specific antigen (PSA) levels • To demonstrate the safety and the local tolerability of the s.c. administration • To determine the pharmacokinetic (PK) profile of triptorelin administered s.c. as a 3 month (M) injection in a subset of 15 patients. Exploratory Objective: • To determine proportion of patients with a serum testosterone level of <20 ng/dL and the characteristics and stability of such a reduction.;Main Objective: To confirm the efficacy of triptorelin pamoate (11.25 mg)prolonged release (PR) formulation by inducing castration (defined as serum testosterone level of <50 ng/dL or <1.735 nmol/L) at Day 29 and maintaining castration at Day 183 (after receiving two subcutaneous (s.c.) administrations of triptorelin pamoate, 3 months apart).;Primary end point(s): •The proportion of patients castrated • The proportion of patients with castration maintained ;Timepoint(s) of evaluation of this end point: •The proportion of patients castrated - Day 29 • The proportion of patients with castration maintained - Day 183 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of patients demonstrating castration at Day 92 • The proportion of patients demonstrating castration at Day 95 • Determination of the time to castration (Tcast) • Plasma triptorelin levels in all patients • Percent change in PSA levels from Baseline in all patients and additionally in patients with elevated PSA levels • Proportion of patients with normal PSA levels • Lack of clinically apparent tumour progression ;Timepoint(s) of evaluation of this end point: The proportion of patients demonstrating castration at Day 92 (before administration of the second dose) • The proportion of patients demonstrating castration at Day 95 (3-4 days after administration of the second dose) • Determination of the time to castration (Tcast) • Plasma triptorelin levels at Days 92 and 183 in all patients • Percent change in PSA levels from Baseline in all patients and additionally in patients with elevated PSA levels at study entry • Proportion of patients with normal PSA levels at Day 183 (End of Study Visit) compared to Baseline • Lack of clinically apparent tumour progression assessed at Day 92 (prior to administration of second dose) and Day 183 (End of Study Visit). | — |
Countries
Bulgaria, France, Latvia, Poland, Romania
Contacts
Public ContactClinical Trials
Ipsen Pharma SAS
Outcome results
None listed