Primary Study ObjectiveTo assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via registered intramuscular (IM) injection…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Variables:
Percentage of patients achieving a plasma testosterone level * 50 ng/dl (1,7
nmol/l) measured at week 24
Secondary outcome
Secondary Efficacy Variables:
Patient acceptability of the injection; the pain experienced during injection,
scored by means of a Visual Analogue Scale (VAS), measured at baseline and 12
weeks
Care giver acceptability of the administration of the injection by means of a
Visual Analogue Scale (VAS), at baseline and 12 weeks
Percentage of patients achieving a plasma testosterone level * 50 ng/dl (1,7
nmol/l) measured at week 12
Background summary
This study, involving 210 patients with prostatic adenocarcinoma is intended to
establish the non inferiority of triptorelin SR 11,25 mg administered via
subcutaneous route every 12 weeks as compared to the registered intra-muscular
administration every 12 weeks and should demonstrate the ability of this
administration route to suppress testosterone below castrate levels at week 24.
The subcutaneous administration route is less painful for the patient and aims
an improvement in patient comfort with sustained efficiancy in comparison with
the registered administration route.
Study objective
Primary Study Objective
To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin®
11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin®
11,25 mg administered via registered intramuscular (IM) injection based on the
percentage of patients presenting a testosterone level * 50 ng/dl at week 24.
Secondary Study Objectives
Overall patient acceptability of SC vs IM injection of Pamorelin® 11,25 mg
Overall caregiver acceptability of SC vs IM injection of Pamorelin® 11,25 mg
To assess the tolerability and safety of SC and IM injections of Pamorelin®
11,25 mg
To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin®
11,25 mg administered via SC injection as compared to Pamorelin® 11,25 mg
administered via standard IM injection based on the percentage of patients
presenting a testosterone level * 50 ng/dl at week 12
Study design
Phase II multi-centric, randomised (1:1), open-label, parallel-group study
Intervention
Group A : Pamorelin® 11,25 mg administered as standard IM injection
Group B : Pamorelin® 11,25 mg administered as a SC injection
Study burden and risks
The burden for the patient participating in this trial consists of 3 blood
collections for the evaluation of the testosteron level and 2 injections (SC or
IM) for the administrations of the study medication.
It is possible that because of the administration of triptorelin the patient
can experience a 'flare up' during the first four weeks of the therapy.
This event is developed because of a temporarily increase of the testosteron
production. During the 'flare up' it is possible that the symptoms, the patient
is experiencing due to his disease, become worse.
Because of the reduction of the testosteron level the patient can experience
fatigue, weight gain, loss of mussle strenght, depression and reduction of
bone density.
Also local adverse events can be experienced from the injection.
Redness, pain, mussle pain (if intra muscular injection), development of
haematoma at the injection site or at the injection site for blood collection.
Based on the text of risk and advantages the treatment presented in this study
is deemed acceptable for the treatment of prostate cancer.
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp
Nederland
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp
Nederland
Listed location countries
Age
Inclusion criteria
Written informed consent
Male patients aged 18 years and older
Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy.
Exclusion criteria
Hypersensitivity to Pamorelin or drugs with similar structure.
Was treated with other IMP within the last 30 days before study entry.
Has previously received a LHRH analogue, estrogens or a steroidal anti-androgen within the last year preceding the study.
Patient who underwent orchidectomy or is scheduled to receive an orchidectomy during the course of this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-005058-31-NL |
| CCMO | NL11895.029.06 |