Neoadjuvant J591 Treatment for Prostate Cancer
A Pilot Study of Neoadjuvant Monoclonal Antibody Humanised (hu) J591 for the Treatment of High and/or Intermediate-Risk Prostate Cancer
Study Overview
Detailed Description
This is an open-label, single center pilot study to evaluate the efficacy of huJ591 to trigger antibody-dependent cellular cytotoxicity (ADCC) response manifested by a peri-tumoral inflammatory response with or without apoptosis of prostate cancer cells in patients diagnosed with either high or intermediate-risk prostate cancer. To participate the patients will be required to meet all eligibility criteria. Patients may not participate in other clinical trials while undergoing therapeutic treatment.
The initial screening period (up to 28 days prior to start of treatment under this clinical trial) consists of visit to confirm eligibility, discuss the risks / benefits of participating in the trial and radical prostatectomy (with or without lymph node dissection), and obtain patient prostate biopsy samples for anti-prostate specific membrane antigen (PSMA) expression review. An enrolled subject's participation in the study entails approximately 6 to 7 weeks of therapy along with the additional 2 weeks time involved in recovery from a radical prostatectomy. Adverse events will be collected throughout the entirety of the study. The total duration of the patient being in the study can be around 9 to 11 weeks. Medical information/Survival information will be collected from the routine followup visits (standard of care) for up to 3 years after the surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: huJ591 followed by 89Zr-J591
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.
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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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
Time Frame: Change from baseline in Peri-tumoral inflammation 4-point scoring at Day 31 post prostatectomy
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Change from baseline in Peri-tumoral inflammation 4-point scoring at Day 31 post prostatectomy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time to biochemical (PSA) and/or radiographic recurrence will be followed by drawing PSA samples and performing radiographic scans.
Time Frame: From date of first treatment until the date of first documented progression or date of death, whichever came first, assessed up to 36 months
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PSA values will be monitored at screening, then at months 3, 6, 9, 12, 18, 24, and 36 after Day 1 of treatment.
Radiographic scans will be performed at screening and at months 6, 12, 18, 24, 30, and 36.
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From date of first treatment until the date of first documented progression or date of death, whichever came first, assessed up to 36 months
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Adverse events will be monitored on Days 1, 14, 21, 28, 31, and 45
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Adverse events will be monitored on Days 1, 14, 21, 28, 31, and 45
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1505016234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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