NCT04925648

Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

PICAASO / CA180-722: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: St Vincent's Hospital, Sydney · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study's purpose is to understand the appearance of your prostate-specific membrane antigen (PSMA) PET scan after you take 14 days of treatment with a drug called dasatinib alone or in combination with anti-testosterone drug call darolutamide. Who is it for? You may be eligible to join this study if you have metastatic prostate cancer and had a recent PSMA scan showing low PSMA uptake Study Details: Participants will receive dasatinib 100 mg daily or dasatinib 100 mg daily and darolutamide 600 mg twice daily for 14 days. They will undergo another PSMA PET scan after 14 days. Participants will be followed up on day 7 of treatment and 30 days after treatment. It is hoped that this research will provide insight into the mechanism of PSMA expression in advanced prostate cancer.

Detailed description

Our group has previously established a strong interaction between the androgen receptor and PSMA receptor in both castrate sensitive and castrate resistant prostate cancers that impacts on the density of PSMA expression. Recent lab studies have also revealed that phospho-SRC inhibition with drugs such as dasatinib can also modulate PSMA expression, in particular in combination with androgen signalling inhibition. If so, this can influence both the timing and use of PSMA PET scans, PSMA based radionuclide therapies and PSMA immunotherapies. In this study we plan to validate and quantify the change in PSMA PET scan SUV when patients undergo a 14 days treatment with dasatinib alone or in combination with an androgen signalling inhibitor (darolutamide).

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Dasatinib	Dasatinib 100mg once daily orally for 14 Days
DRUG	Darolutamide	Darolumatide 600 mg twice daily orally for 14 Days

Timeline

• Start date: 2021-10-18
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2021-06-14
• Last updated: 2025-05-15

Locations

2 sites across 1 country: Australia