NCT04868604 · Clarity Pharmaceuticals Ltd
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
(SECuRE)
What this study is about
The aim of this study is to determine the safety and effectiveness of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
View original scientific description
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.
Interventions
DRUG
64Cu-SAR-bisPSMA
64Cu-SAR-bisPSMA
DRUG
67Cu-SAR-bisPSMA
67Cu-SAR-bisPSMA
Primary outcome measures
Biodistribution of 64Cu-SAR-bisPSMA
Time frame: 48 hours
Biodistribution will be calculated by utilizing the PET/CT scans.
Dosimetry of 64Cu-SAR-bisPSMA
Time frame: 48 hours
Dosimetry will be calculated by utilizing the PET/CT scans.
Modelling of 67Cu-SAR-bisPSMA dosimetry utilizing the 64Cu-SAR-bisPSMA PET/CT scans
Time frame: 48 hours
Dosimetry will be calculated by utilizing the PET/CT scans.
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose of a single dose of 67Cu-SAR-bisPSMA
Time frame: 8 weeks
MDT as determined by cohort observations of dose limiting toxicities (DLT)
Recommended dose of two doses of 67Cu-SAR-bisPSMA
Time frame: 14 weeks
Recommended dose as determined by cohort observations of DLTs
Efficacy of 67Cu-SAR-bisPSMA in terms of Prostate specific Antigen (PSA) response
Time frame: Up to 5 years
Proportion of participants with ≥50% decline in PSA
Efficacy of 67Cu-SAR-bisPSMA in terms of radiographic response
Time frame: Up to 5 years
Efficacy will be assessed via the overall response rate according to RECIST V1.1 for soft tissue disease and according PCWG3 for bone lesions
Incidence of 67Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 5 years
Adverse Events will be as assessed by CTCAE version 5.00
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in Vital Signs
Time frame: Up to 1 year
Change from baseline in vital signs
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in electrocardiogram (ECG) parameters
Time frame: Up to 24 weeks
Change from baseline in ECG parameters
Safety and tolerability of 67Cu-SAR-bisPSMA: Number of Participants With Changes from baseline in laboratory results
Time frame: Up to 22 weeks
Change from baseline in laboratory results
Incidence of 64Cu-SAR-bisPSMA Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 5 years
Adverse Events will be as assessed by CTCAE version 5.00
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \<1.7 nmol/L);
- Have progressive metastatic castration-resistant prostate cancer (mCRPC) despite prior androgen deprivation therapy and:
- Dose Escalation: at least either enzalutamide and/or abiraterone (or other such androgen receptor pathway inhibitors \[androgen receptor pathway inhibitorsARPIs\]).
- Cohort Expansion Main Group: Participant has progressed once or twice on a prior second generation ARPI (abiraterone, enzal
Where
- Stanford, California
- River Ridge, Louisiana
- Grand Rapids, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- Omaha, Nebraska
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations