Movember substudy

A study on the pharmacokinetics of [18F]-fluordihydrotestosterone in patients with metastasized castrate resistant prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26162

Enrollment

Registered

2014-04-10

Start date

2014-06-02

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

matastasized castrate resistent prostate cancer

Interventions

A 10 min PET study after intravenous (iv) administration of [15O]-water, followed by a second 30 min dynamic PET study directly after [18F]FDHT administration, and a 30 min skull base-mid thigh half b

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with mCRPC eligible for the GAP2-FDHT study - Written informed consent - Patients able to remain supine for 70 minutes

Exclusion criteria

Exclusion criteria: - Claustrophobia - Multiple malignancies - Use of anticoagulantia - Renal failure (GFR <30ml/min/1,73m2) - Known hypersensitivity to Gadovist

Design outcomes

Primary

Measure	Time frame
A pharmacokinetic model for [18F]FDHT; an appropriate simplified quantitative method for [18F]FDHT; concordance of DCE-MRI and [15O]-water parameters.	—

Secondary

Measure	Time frame
not apllicable	—

Contacts

Public ContactO.S. Hoekstra

Department of Nuclear Medicine & PET Research VU University medical center (VUmc) P.O. Box 7057

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)