Tiny trial aims to shed light on PSMA scans in hard-to-treat prostate cancer
NCT ID NCT04925648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking dasatinib alone or with darolutamide for 14 days can increase PSMA levels on PET scans in men with metastatic prostate cancer. Only 4 men participated, all with low PSMA uptake on their initial scan. The goal was to learn more about how PSMA expression works, not to treat the cancer directly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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4 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kinghorn Cancer Centre, St. Vincent's Hospital
Sydney, New South Wales, 2010, Australia
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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