Actively Recruiting
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Led by Clarity Pharmaceuticals Ltd · Updated on 2026-05-06
54
Participants Needed
7
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status 0 to 2
- Life expectancy greater than 6 months
- Confirmed diagnosis of prostate cancer
- Positive 64Cu-SAR-bisPSMA PET/CT scan with uptake higher than liver in at least one lesion
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
- Progressive metastatic castration-resistant prostate cancer despite prior androgen deprivation therapy and specific prior treatments with androgen receptor pathway inhibitors
- At least one metastatic lesion present on recent imaging within 28 days prior to enrollment
- Recovery to Grade 2 or less from all significant toxicities related to prior therapies
- Adequate organ function including specified blood counts, liver enzymes, and kidney function
- For participants with HIV, must be healthy with low risk of AIDS-related outcomes
- Use of adequate birth control methods if participant or partner is of childbearing potential
You will not qualify if you...
- Major surgery within 12 weeks prior to enrollment
- Brain metastases
- Small cell or neuroendocrine prostate cancer diagnosis
- History of leukemia or myelodysplastic syndrome
- Recent diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks
- Unmanageable urinary tract obstruction
- PSMA-negative progressive lesions on PET/CT scan at screening (with exceptions)
- Previous systemic radionuclide treatments within specified timeframes without approval
- Recent systemic anti-cancer therapy within 4 weeks prior to study treatment
- Prior chemotherapy within 4 weeks for dose escalation group
- Prior cytotoxic chemotherapy for castration resistant prostate cancer in cohort expansion
- Prior investigational agents within 4 weeks
- Known hypersensitivity to study drugs
- Transfusion only to meet eligibility
- Spinal metastasis with symptomatic or impending cord compression
- Serious concurrent medical conditions that impair participation
- Other malignancies affecting life expectancy or disease assessment unless disease-free for over 3 years
- Conditions posing unacceptable radiation safety risks
- Planned external beam radiation therapy after enrollment (with exceptions)
- In the concomitant enzalutamide group: hypersensitivity to enzalutamide, history of seizures, recent loss of consciousness or transient ischemic attack, and conditions increasing seizure risk
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
2
East Jefferson General Hospital
River Ridge, Louisiana, United States, 70123
Actively Recruiting
3
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Washington University School of Medicine at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
6
XCancer
Omaha, Nebraska, United States, 68130
Actively Recruiting
7
Weill Cornell Medicine at New York-Presbyterian
New York, New York, United States, 10021
Actively Recruiting
Research Team
C
Clarity Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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