TheranosticTrials.org

Clinical Trial · NCT02693860

Neoadjuvant J591 Treatment for Prostate Cancer

Overview

10 patients will be enrolled in the initial cohort and will receive two infusions of unlabeled huJ591 on days 1 and 14. 89Zr-J591 will be administered on day 21 (+ 1 day) and a positron emission tomography-computed tomography (PET/CT) will be performed week later on day 28 + 1 (visit 4). Approximately 2 to 3 weeks after the 2nd dose of J591, the patient will undergo radical prostatectomy with or without lymph node dissection (day 31 + 4 days). The final visit for the study will include a postoperative visit two weeks following surgery.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Scott Tagawa, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02693860

Drug / Compound

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Intermediate or high risk prostate cancer defined by:
  • Any Gleason with PSA between 10 and 20 ng/mL
  • Intermediate risk prostate cancer defined as:
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
  • Gleason grade \> 8
  • High risk (any one of the following):
  • Gleason grade 4+3 with more than 3 cores involved with \> 20% of volume involved
  • Any Gleason with PSA above 20 ng/mL
  • Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry
  • Histologically confirmed diagnosis of prostate cancer
  • Gleason grade = 7
  • Gleasone \> 4+3 and tumor stage clinical T3 or above

Exclusion

  • Serum creatinine \> 3x upper limit of normal (ULN)
  • On any other new anticancer therapy between screening and prostatectomy
  • Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT or SGOT) \> 2.5x ULN
  • Bilirubin (total) \> 1.5 x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits
  • Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation
  • Frank metastasis identified during clinical staging
  • Patient ineligible for radical prostatectomy for any other reason