Changing PSMA levels in metastatic prostate cancer with dasatinib and darolutamide
PICAASO / CA180-722: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
This study tests how a new treatment with dasatinib, alone or with darolutamide, affects PSMA levels in men with metastatic prostate cancer over 14 days.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | St Vincent's Hospital, Sydney Academic / other |
| Drugs / interventions | dasatinib |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT04925648 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how the prostate-specific membrane antigen (PSMA) levels change in patients with metastatic prostate cancer after 14 days of treatment with dasatinib, either alone or in combination with darolutamide, an anti-testosterone drug. Participants will undergo a PSMA PET scan before and after the treatment to assess changes in PSMA expression. The study seeks to understand the interaction between androgen signaling and PSMA expression, which could influence future imaging and treatment strategies for advanced prostate cancer. Follow-up assessments will occur at specified intervals to monitor patient response and safety.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with metastatic castrate-resistant prostate cancer and low PSMA uptake on recent scans.
Not a fit: Patients who have previously received dasatinib or have significant allergies to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging and treatment strategies for patients with advanced prostate cancer.
How similar studies have performed: Previous studies have shown promising results in modulating PSMA expression with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sydney, New South Wales and 1 other locations
- Kinghorn Cancer Centre, St. Vincent's Hospital — Sydney, New South Wales, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Anthony Joshua, FRACP, MBBS, PhD
- Email: Anthony.Joshua@svha.org.au
- Phone: +61 293555655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.