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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
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.
Sponsor:
Clarity PharmaceuticalsContacts:
Clarity Pharmaceuticals (Clarity Clinical)clinicaltrials@claritypharmaceuticals.com
+61 0 2 9209 4037
Government Study Link:
NCT04868604 - Click here to see study onClinicalTrials.gov
- •≥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
- •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
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
XCancer - Omaha
17607 Gold Plaza, Omaha, Nebraska 68130, United States
Principal Investigator
Luke T. Nordquist, MD
Weill Cornell Medicine at New York - Presbyterian
New York, New York 10021, United States
Principal Investigator
Scott Tagawa, MD
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Principal Investigator
Geoffrey Johnson, MD
Stanford Cancer Institute
Stanford, California 94305, United States
Principal Investigator
Hong Song, MD, Ph.D.
Washington University School of Medicine
St. Louis, Missouri, United States
Principal Investigator
Vikas Prasad, MD
St. Vincent's Hospital
Sydney, New South Wales, Australia
Principal Investigator
Professor Louise Emmett, MBChB, FRACP, FAANMS, MD
