Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer (DKP 3M SC)

Ipsen

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin Pamoate 11.25mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01715129

2012-001279-35 (EudraCT Number)

8-55-52014-200

Details and patient eligibility

About

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

Enrollment

126 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.