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Neoadjuvant J591 Treatment for Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

huJ591

89Zr-J591

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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):
  1. Gleason grade > 8
  2. Gleason grade 4+3 with more than 3 cores involved with > 20% of volume involved
  3. Any Gleason with PSA above 20 ng/mL
  4. Gleasone > 4+3 and tumor stage clinical T3 or above
- Intermediate risk prostate cancer defined as:
  1. Gleason grade = 7
  2. 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

Sites / Locations

Weill Cornell Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

huJ591 followed by 89Zr-J591

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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

Full Information

NCT ID

NCT02693860

First Posted

February 12, 2016

Last Updated

October 1, 2020

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT02693860

Brief Title

Neoadjuvant J591 Treatment for Prostate Cancer

Official Title

A Pilot Study of Neoadjuvant Monoclonal Antibody Humanised (hu) J591 for the Treatment of High and/or Intermediate-Risk Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 4, 2016 (Actual)

Primary Completion Date

February 10, 2017 (Actual)

Study Completion Date

February 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

huJ591 followed by 89Zr-J591

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

huJ591

Other Intervention Name(s)

J591

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

89Zr-J591

Other Intervention Name(s)

radiolabeled J591

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Tagawa, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant J591 Treatment for Prostate Cancer

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