None listed
Conditions
Brief 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.
Interventions
The phase 2 study will recruit men with confirmed metastatic castrate-resistant prostate cancer who have recently undergone a PSMA PET scan. Eligible participants will be assigned to either:
- Cohort A: Dasatinib 100mg once daily orally for 14 Days
- Cohort B: Dasatinib 100mg once daily and Darolumatide 600 mg twice daily orally for 14 Days
Participants can only be assigned to Cohort B once all available slots to Cohort A are filled and reviewed by investigators.
After 7 days of treatment, p
The phase 2 study will recruit men with confirmed metastatic castrate-resistant prostate cancer who have recently undergone a PSMA PET scan. Eligible participants will be assigned to either: - Cohort A: Dasatinib 100mg once daily orally for 14 Days - Cohort B: Dasatinib 100mg once daily and Darolumatide 600 mg twice daily orally for 14 Days Participants can only be assigned to Cohort B once all available slots to Cohort A are filled and reviewed by investigators. After 7 days of treatment, participants will be assessed by an investigator. After 14 (+/- 2 days) of treatment the participant will be re-imaged with a PSMA PET scan. Participants will be asked to maintain a record of drug dosing. A safety visit is scheduled at 30 days post treatment.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male, aged 18 years or older 2. Pathologically confirmed adenocarcinoma of prostate or a clinical presentation consistent with prostate cancer 3. 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 4. Adequate hematologic and organ function within 14 days before the first study treatment 5. Castrate levels of testosterone < 1.7 ng/ml 6. Provision of written informed consent.
Exclusion criteria
1. Patients who cannot lie still for at least 30 minutes or comply with imaging. 2. Previous dasatinib for prostate cancer or other condition, eg CLL 3. Allergy to dasatinib or darolutamide 4. Use of drugs that interact with interact pharmacologically with dasatinib within 1 week of study entry eg Use of CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or St John’s Wort) and use of CYP3A4 substrates with narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot analogues. 5. Use Concomitant use of H2 antagonists or proton pump inhibitors. 6. Current or previous (within the last 6 months) pleural effusion 7. Use of paracetamol during the study period 8. Subjects may not have any of the following: Clinical evidence of uncontrolled heart failure, myocardial infarction, or angina within the previous 6 months; prolonged QT interval Fridericia's (QTcF) > 450msec; history of unstable ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation, or torsades de pointes); concomitant use of drugs known to cause torsades de pointes [quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine,thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl,pentamidine, sparfloxacin, lidoflazine] (these agents must have been discontinued at least 7 days prior to starting dasatinib) 9. Subjects may not be enrolled with any of the following: History of a significant bleeding disorder unrelated to cancer, including diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), and diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies); GI bleeding from any cause within 3 months
Outcome results
None listed