Study to evaluate the efficay, safety and local tolerability of triptorelin pamoate (11,25mg) injected sub cuteanously in patients with (locally advanced or metastatic) prostate cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 120

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

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 <9 g/dL, absolute neutrophil count =1.5 x 109/L or platelets =100 x 109/L
• Serum creatinine =1.5 times the upper limit of normal (ULN)
• Aspartate aminotransferase or alanine aminotransferase >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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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