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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Androgen Deprivation Therapy (ADT)+Brachytherapy+Hypofractionated Pelvic External Beam Radiation
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male, aged 18 years or older

• Pathologically confirmed adenocarcinoma of prostate or a clinical presentation consistent with prostate cancer

• Metastatic castrate resistant prostate cancer previously confirmed on 68Ga-PSMA-11 and 18F-FDG imaging to be inadequate for future PSMA-directed theranostic treatment by a nuclear medicine physician based on FDG-discordance (FDG-positive, PSMA-negative sites of disease) OR low PSMA SUV values within 2 weeks of starting study drug

• Adequate hematologic and organ function within 14 days before the first study treatment

• Castrate levels of testosterone \< 1.7 ng/ml

• Provision of written informed consent.

Locations
Other Locations
Australia
Peter MacCallum Cancer Centre
NOT_YET_RECRUITING
Melbourne
Kinghorn Cancer Centre, St. Vincent's Hospital
RECRUITING
Sydney
Contact Information
Primary
Anthony Joshua, FRACP, MBBS, PhD
Anthony.Joshua@svha.org.au
+61 293555655
Backup
Robert Kent
SVHS.CancerResearch@svha.org.au
+61 293555611
Time Frame
Start Date: 2021-10-18
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 22
Treatments
Active_comparator: Cohort A
Dasatinib 100mg once daily orally for 14 Days
Active_comparator: Cohort B
Dasatinib 100mg once daily and Darolumatide 600 mg twice daily orally for 14 Days
Related Therapeutic Areas
Sponsors
Leads: St Vincent's Hospital, Sydney

This content was sourced from clinicaltrials.gov