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

Phase 2

Recruiting

• Conditions: metastasized castrate resistent prostate cancer; Prostate cancer; 10038597

• Registration Number: NL-OMON50549
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 36

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 <= 50 ng/dL.
4. Written informed consent, Substudy:
1. Inclusion in the Movember GAP2 project
2. Written informed consent
3. Patients have to be able to remain supine for 70 minutes

Exclusion Criteria

1. Patients already on enzalutamide or other antiandrogens
2. Contraindications for MRI, Sub-study
1. Claustrophobia
2. Multiple malignancies
3. Hb < 6.0 mmol/L
4. Renal insufficiency (GFR < 30 mL/min/1.73m2)
5. Known hypersensitivity to Gadovist

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>