No registrations found.
ID
Source
Brief title
Health condition
Prostate Cancer, LHRH-agonists, androgen deprivation therapy, ADT, testosterone-based dosering
Prostaat kanker, LHRH-agonisten, androgeen deprivatie therapie, ADT, testosteron gebaseerd doseren
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean number of goserelin 10.8mg injections per patient during follow-up.
Secondary outcome
Difference in time to castrate refractory disease in the testosterone based regimen compared to regular treatment with a 3-monthly based goserelin 10.8 mg injection, during 24 months follow-up.
Difference in treatment costs per patient in the testosterone based regimen compared to regular treatment with a 3-monthly based goserelin 10.8 mg injection, including:
Depot injections of goserelin 10.8 mg
Laboratory tests
Outpatient monitoring
Other medication and surgical interventions related to the disease
Complications after a surgery related to the disease
Background summary
Chemical or surgical castration is a key strategy in patients with locally advanced or metastatic prostate cancer. The goal is to eliminate gonadal testosterone production, so called castration. Currently, both chemical and surgical castration are considered equal modalities to achieve castration. Chemical castration is achieved by administering Luteinizing Hormone Releasing Hormone (LHRH) agonists on a regular basis. However, after prescribing LHRH agonists, physicians do not monitor the testosterone levels routinely. Moreover, current dosing regimens are manufacturer recommended. Several studies have shown that serum testosterone levels remain longer at or below castrate levels when 3monthly depot injections of LHRH agonists are administered. This opens opportunities for a personalized way of dosing LHRH agonists depending on the testosterone level. However, in the performed testosterone based dosing studies only the LHRH agonist leuprorelin has been investigated. The current study will be initiated to evaluate a testosterone based dosing regimen with depot injections of goserelin 10.8 mg for all eligible patients as well as subgroups of patients. Based on the performed testosterone based dosing studies with leuprorelin we expect that the dosing interval of depot injections of goserelin 10.8 mg can be prolonged to 5 or 6 months. An effective personalized treatment regimen will probably lower the treatment burden (for patients) and treatment costs (for society) while treatment goals are still achieved.
Study objective
The primary objective of this study is to determine the possibility to extend the dosing interval of goserelin 10.8 mg with a testosterone-based dosing regimen compared to regular treatment with 3-monthly based goserelin 10.8 mg injections during 24 months follow-up.
Study design
Control group: once every 3 months
Intervention group: dependent on the testosterone levels in the patients
Intervention
Extending the dosing interval of goserelin 10.8 mg injections
M.B. Mulder
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
010-4616096
m.mulder@franciscus.nl
M.B. Mulder
Kleiweg 500
Rotterdam 3045 PM
The Netherlands
010-4616096
m.mulder@franciscus.nl
Inclusion criteria
Informed consent
Male > 18 years
Diagnosed with prostate cancer with a clinical indication for ADT (≥2 years or permanently)
Patients can be included before the first injection of goserelin 10.8mg and in the first two months after the first injections of goserelin 10.8 mg.
Exclusion criteria
Patients receiving anti-androgens (excluding bicalutamide for 4 weeks around the first LHRH agonist)
Patients with a history of hypersensitivity to LHRH agonists
Patients not able to visit hospital’s laboratory for blood sampling
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6353 |
| NTR-old | NTR6537 |
| CCMO | NL60691.101.17 |
| OMON | NL-OMON45500 |