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Clinical Trial · NCT04868604
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
Overview
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.
Sponsor
Clarity PharmaceuticalsPhase
Phase 1/2
Contacts
Clarity Pharmaceuticals (Clarity Clinical)
clinicaltrials@claritypharmaceuticals.com
+61 0 2 9209 4037
ClinicalTrials.gov
NCT04868604Eligibility
Inclusion
- •≥1 metastatic lesion that is present at screening CT, MRI, or bone scan imaging ≤28 days prior to enrolment
- •Histological, pathological, and/or cytological confirmation of Prostate cancer (PCa)
- •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
- •Eastern Cooperative Oncology Group performance status of 0 to 2
Exclusion
- •Spinal metastasis with symptomatic cord compression, or clinical or radiologic indicative findings
- •Prior history of leukemia or Myelodysplastic Syndrome
- •Symptomatic Brain metastasis
- •Histologic diagnosis of small cell or neuroendocrine prostate cancer
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