Neoadjuvant J591 Treatment for Prostate Cancer

NCT02693860 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1505016234
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Induction of inflammatory and/or apoptotic response of prostate cancer cells by reviewing H&E stained slides from pre treatment biopsy and comparing to the post-treatment radical prostatectomy pathology using the Peri-tumoral inflammation 4-point scoring

  Change from baseline in Peri-tumoral inflammation 4-point scoring at Day 31 post prostatectomy

Secondary Outcomes (2)

• Time to biochemical (PSA) and/or radiographic recurrence will be followed by drawing PSA samples and performing radiographic scans.

  From date of first treatment until the date of first documented progression or date of death, whichever came first, assessed up to 36 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Adverse events will be monitored on Days 1, 14, 21, 28, 31, and 45

Study Arms (1)

huJ591 followed by 89Zr-J591

EXPERIMENTAL

Subjects will receive two infusions of unlabeled huJ591 on days 1 and 15 (+/- 1 day). 89Zr-J591 will be administered on day 22 (+/- 1 day) and 5-8 days later. PET/CT will be performed followed by repeat imaging of the prostate. Radical prostatectomy with or without lymph node dissection is performed 2 to 4 weeks after the second dose of J591.

Drug: huJ591; Drug: 89Zr-J591

Interventions

huJ591 DRUG

Antibody is derived from a hybridoma originally produced in the Weill Medical College Laboratory of Urological Oncology. Treatment with 100 mg of HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of \<5 mg/minute.

Also known as: J591

huJ591 followed by 89Zr-J591

89Zr-J591 DRUG

Drug product is manufactured by the radiochemistry staff of Citigroup Biomedical Imaging Center (CBIC) research core facility. Radiolabeling of DFO-huJ591 with 89Zr is achieved by the addition of 89Zr-oxalate to the DFO-huJ591 in ammonium acetate buffer.

Also known as: radiolabeled J591

huJ591 followed by 89Zr-J591

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

J591 monoclonal antibody

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Scott Tagawa, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 29, 2016
• Study Start: February 4, 2016
• Primary Completion: February 10, 2017
• Study Completion: February 2, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)