64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer
About This Trial
- This clinical trial is studying a new targeted radiation treatment designed to find and destroy advanced prostate cancer cells throughout the body.
- It is for adults whose prostate cancer has spread and continues to grow even after receiving standard hormone treatments.
- Before joining, patients will receive a special scan to confirm that their tumors have a specific protein marker needed for the medication to work.
- Patients should also know that they must have adequate organ function and cannot have cancer that has spread to the brain or have recently received certain other radiation therapies.
More Information
- The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is studying a new targeted radiation treatment designed to find and destroy advanced prostate cancer cells throughout the body.
Study Details
- Start Date: August 11, 2021
- Lead Sponsor: Clarity Pharmaceuticals Ltd
Full Eligibility Criteria
Inclusion Criteria
- Signed informed consent;
- ≥18 years of age;
- Eastern Cooperative Oncology Group performance status of 0 to 2;
- Life expectancy >6 months;
- Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa);
- Positive 64Cu-SAR-bisPSMA PET/CT scan, where 64Cu-SAR-bisPSMA uptake (standardized uptake value [SUV] max) of at least 1 known lesion is higher than that of the liver on the 1 hour positron emission tomography (PET)/computed tomography (CT) scan;
- Castrate level of serum/plasma testosterone (<50 ng/dL or 179 or diastolic >105), patients undergoing alcohol withdrawal.
Treatments
- Drug: 64Cu-SAR-bisPSMA
- Drug: 67Cu-SAR-bisPSMA