Testosterone based dosing regimen of goserelin in patients with prostate cancer

Testosterone based dosing regimen of goserelin in patients with prostate cancer - TEST-TOSTERON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54398

Enrollment

Registered

2021-12-28

Start date

2022-07-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer prostate tumour

Interventions

A conservative algorithm will be applied to ensure that testosterone will remain at castrate level (below 1.7 nmol/L). Approximately 11 weeks after the third depot injection of goserelin 10.8 mg, bl

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Informed consent - >= 18 years - Diagnosed with prostate cancer with an indication for Androgen Deprivation Therapy (>= 2 years or permanently)

Exclusion criteria

Exclusion criteria: - Patients with a history of hypersensitivity to LHRH agonists - Patients not able to visit hospital*s laboratory for blood sampling - Patients with a serum testosterone > 1.2 nmol/L while treated with LHRH therapy (patients who fail on LHRH therapy, in the first half year of treatment) - Concurrent systemic anti- cancertherapy other than goserelin

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the percentage (%) of patients for whom the dosing interval before the fourth goserelin 10.8 mg injection can safely be extended with 4 weeks using a testosterone based dosing regimen.	—

Secondary

Measure	Time frame
The percentage (%) of patients, that can safely extend the dosing interval of the 4th goserelin injection with 8 or 12 weeks, using a testosterone based dosing regimen. The percentage (%) of patients, for whom the dosing interval of the fourth injection was extended with maximum 12 weeks, that can safely extend the dosing interval of the 5th goserelin 10,8 mg injection with 4, 8 or 12 weeks, using a testosterone level-based dosing regimen The percentage of patients indicating an overall preference for testosterone-based dosing regimen or regular treatment with a 12- weekly based dosing regimen. Patient is its own control. Difference in treatment costs per patient in the testosterone based regimen compared to regular treatment with a 12-weekly 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 - Our data will be compared to data published in previous studies. Overview of the metabolome of testosterone.	—

Measure

Time frame

The percentage (%) of patients, that can safely extend the dosing interval of the 4th goserelin injection with 8 or 12 weeks, using a testosterone based dosing regimen. The percentage (%) of patients, for whom the dosing interval of the fourth injection was extended with maximum 12 weeks, that can safely extend the dosing interval of the 5th goserelin 10,8 mg injection with 4, 8 or 12 weeks, using a testosterone level-based dosing regimen The percentage of patients indicating an overall preference for testosterone-based dosing regimen or regular treatment with a 12- weekly based dosing regimen. Patient is its own control. Difference in treatment costs per patient in the testosterone based regimen compared to regular treatment with a 12-weekly 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 - Our data will be compared to data published in previous studies. Overview of the metabolome of testosterone.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)