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

NCT04925648 | Completed Phase 2

• 1 other identifier: PICASSO
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To quantify the increase in tumour (standard uptake value) SUV measurements comparing baseline to 2-week PSMA PET scans in men being treated with dasatinib alone or in combination with darolutamide

  Primary outcome

  14 days

Secondary Outcomes (1)

• To determine the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after a 14-day course of dasatinib alone or in combination with darolutamide in men with castrate resistant prostate cancer

  14 days

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

Dasatinib 100mg once daily orally for 14 Days

Drug: Dasatinib

Cohort B

ACTIVE COMPARATOR

Dasatinib 100mg once daily and Darolumatide 600 mg twice daily orally for 14 Days

Drug: Dasatinib; Drug: Darolutamide

Interventions

Dasatinib DRUG

Dasatinib 100mg once daily orally for 14 Days

Cohort A; Cohort B

Darolutamide DRUG

Darolumatide 600 mg twice daily orally for 14 Days

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who cannot lie still for at least 30 minutes or comply with imaging.
• Previous dasatinib for prostate cancer or other condition, eg CLL
• Allergy to dasatinib or darolutamide
• 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.
• Use Concomitant use of H2 antagonists or proton pump inhibitors.
• Current or previous (within the last 6 months) pleural effusion
• Use of paracetamol during the study period
• 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)
• 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

Sponsors & Collaborators

• St Vincent's Hospital, Sydney: lead

Study Sites (2)

Kinghorn Cancer Centre, St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dasatinib; darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology, The Kinghorn Cancer Centre

Model Details: Prospective, non-randomised pilot study

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: June 14, 2021
• Study Start: October 18, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)