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Less injections by androgen scrutinisation


- candidate number27430
- NTR NumberNTR6537
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jun-2017
- Secondary IDsNL60691.101.17 MEC
- Public TitleLess injections by androgen scrutinisation
- Scientific TitleLess injections by androgen scrutinisation
- ACRONYMMIDAS
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Androgen deprivation
- Inclusion criteriaInformed 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 criteriaPatients 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 hospitalís laboratory for blood sampling
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2017
- planned closingdate1-jan-2020
- Target number of participants42
- InterventionsExtending the dosing interval of goserelin 10.8 mg injections
- Primary outcomeMean number of goserelin 10.8mg injections per patient during follow-up.
- Secondary outcomeDifference 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
- TimepointsControl group: once every 3 months
Intervention group: dependent on the testosterone levels in the patients
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.B. Mulder
- CONTACT for SCIENTIFIC QUERIES M.B. Mulder
- Sponsor/Initiator Franciscus Gasthuis
- Funding
(Source(s) of Monetary or Material Support)
Franciscus Gasthuis
- Publications
- Brief summaryChemical 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.
- Main changes (audit trail)
- RECORD20-jun-2017 - 25-jul-2017


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