[18-F]-Fluordihydrotestosterone PET and [18F]-prostate specific membrane antigen in metastasized castrate resistant prostate cancer

[18-F]-Fluordihydrotestosterone PET and [18F]-prostate specific membrane antigen in metastasized castrate resistant prostate cancer - Movember GAP2 project

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50549

Enrollment

Registered

2014-08-06

Start date

2015-02-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

metastasized castrate resistent prostate cancer Prostate cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1: Histologically or cytologically proven metastatic CRPC. 2. Progressive disease based on any of the following: (a) a rise in PSA through 3 consecutive measurements (b) progressive disease by virtue of transaxial imaging based on RECIST 1.1 (c) radionuclide bone scan showing at least two new metastatic lesions. 3. Patients will have castrate levels of serum testosterone

Exclusion criteria

Exclusion criteria: 1. Patients already on enzalutamide or other antiandrogens 2. Contraindications for MRI, Sub-study 1. Claustrophobia 2. Multiple malignancies 3. Hb

Design outcomes

Primary

Measure	Time frame
A definition of the performance characteristics of FDHT PET in patients with mCRPC. Definition of the relationship between FDHT uptake and tumor diffusivity as assessed by whole-body MRI as well as with AR expression, serum androgen levels, androgen levels in biopsy specimens, CTC enumeration, ARV7 presence, and ARV7 nuclear localization. Correlation between PSA and radiological progression free survival time and change in PSMA uptake en MRI from baseline. Sub-study: A pharmacokinetic model for [18F]FDHT; an appropriate simplified quantitative method for [18F]FDHT; concordance of DCE-MRI and [15O]- water parameters.	—

Measure

Time frame

A definition of the performance characteristics of FDHT PET in patients with mCRPC. Definition of the relationship between FDHT uptake and tumor diffusivity as assessed by whole-body MRI as well as with AR expression, serum androgen levels, androgen levels in biopsy specimens, CTC enumeration, ARV7 presence, and ARV7 nuclear localization. Correlation between PSA and radiological progression free survival time and change in PSMA uptake en MRI from baseline. Sub-study: A pharmacokinetic model for [18F]FDHT; an appropriate simplified quantitative method for [18F]FDHT; concordance of DCE-MRI and [15O]- water parameters.

—

Countries

Netherlands

Outcome results