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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04925648
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Anthony Joshua, FRACP, St Vincent's Hospital, Sydney

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.


Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: Dasatinib Drug: Darolutamide Phase 2

Detailed Description:
Our group has previously established a strong interaction between the androgen receptor and PSMA receptor in both castrate sensitive and castrate resistant prostate cancers that impacts on the density of PSMA expression. Recent lab studies have also revealed that phospho-SRC inhibition with drugs such as dasatinib can also modulate PSMA expression, in particular in combination with androgen signalling inhibition. If so, this can influence both the timing and use of PSMA PET scans, PSMA based radionuclide therapies and PSMA immunotherapies. In this study we plan to validate and quantify the change in PSMA PET scan SUV when patients undergo a 14 days treatment with dasatinib alone or in combination with an androgen signalling inhibitor (darolutamide).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, non-randomised pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PICAASO / CA180-722: Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
Actual Study Start Date : October 18, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Dasatinib

Arm Intervention/treatment
Active Comparator: Cohort A
Dasatinib 100mg once daily orally for 14 Days
Drug: Dasatinib
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
Drug: Dasatinib
Dasatinib 100mg once daily orally for 14 Days

Drug: Darolutamide
Darolumatide 600 mg twice daily orally for 14 Days




Primary Outcome Measures :
  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 [ Time Frame: 14 days ]
    Primary outcome


Secondary Outcome Measures :
  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 [ Time Frame: 14 days ]
    Secondary outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925648


Contacts
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Contact: Anthony Joshua, FRACP, MBBS, PhD +61 293555655 Anthony.Joshua@svha.org.au
Contact: Robert Kent +61 293555611 SVHS.CancerResearch@svha.org.au

Locations
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Australia, New South Wales
Kinghorn Cancer Centre, St. Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Robert Kent    0293555611    SVHS.CancerResearch@svha.org.au   
Australia, Victoria
Peter MacCallum Cancer Centre Not yet recruiting
Melbourne, Victoria, Australia, 3000
Contact: Arun Azad, FRACP, MBBS, PhD       arun.azad@petermac.org   
Sponsors and Collaborators
St Vincent's Hospital, Sydney
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Responsible Party: Anthony Joshua, FRACP, Head of Medical Oncology, The Kinghorn Cancer Centre, St Vincent's Hospital, Sydney
ClinicalTrials.gov Identifier: NCT04925648    
Other Study ID Numbers: PICASSO
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan to share participant data with individuals outside this trial

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action