Status:
COMPLETED
Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)
Lead Sponsor:
Clarity Pharmaceuticals Ltd
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
Detailed Description
This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (...
Eligibility Criteria
Inclusion
- Signed informed consent;
- ≥18 years of age;
- Life expectancy \>3 months;
- Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
- Have ≥1 of the following intermediate- to high-risk features:
- PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
- International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
- Clinical stage greater than or equal to T2b;
- Participants must have adequate renal function;
- Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
- A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.
Exclusion
- Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
- Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
- Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
- Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
- Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04839367
Start Date
July 13 2021
End Date
October 19 2022
Last Update
January 17 2023
Active Locations (3)
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1
Nepean Hospital
Kingswood, New South Wales, Australia, 2751
2
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
3
GenesisCare CTA, SJOG Medical Clinic
Murdoch, Western Australia, Australia, 6150