Prostatic Neoplasms Clinical Trial
— PROPELLEROfficial title:
Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study
Verified date | January 2023 |
Source | Clarity Pharmaceuticals Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 19, 2022 |
Est. primary completion date | October 19, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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: 1. PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment; 2. International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above; 3. 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Nepean Hospital | Kingswood | New South Wales |
Australia | GenesisCare CTA, SJOG Medical Clinic | Murdoch | Western Australia |
Australia | St. Vincent's Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Clarity Pharmaceuticals Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5 | Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting. | 11 weeks | |
Primary | Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology | Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology. | 11 weeks | |
Secondary | Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq). | Image quality will be assessed by 2 blinded central readers. | 11 weeks |
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