Neoadjuvant J591 Treatment for Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02693860

Run by

Weill Medical College of Cornell University

People needed

8

Starts

2016-02-04

Expected to finish

2020-02-02

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adult male > 18 years of age
• Histologically confirmed diagnosis of prostate cancer
• Intermediate or high risk prostate cancer defined by:
• High risk (any one of the following):
• Gleason grade > 8
• Gleason grade 4+3 with more than 3 cores involved with > 20% of volume involved
• Any Gleason with PSA above 20 ng/mL
• Gleasone > 4+3 and tumor stage clinical T3 or above
• Intermediate risk prostate cancer defined as:
• Gleason grade = 7
• Any Gleason with PSA between 10 and 20 ng/mL
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
• Ability to understand and willingness to sign a written informed consent document
• Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry

You may not qualify if…

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

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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