Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PSMA Imaging of Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675451
Recruitment Status : Completed
First Posted : September 18, 2018
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The present study is a phase II, open label, single-center, non-randomized, single-dose study.

Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.

The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa).

After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.

2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.

(they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion)

Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.

Patient will undergo radical prostatectomy after completion of above imaging procedures.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 89ZR-DF-IAB2M Drug: 68Ga-PSMA-HBED-CC Phase 2

Detailed Description:
The primary endpoint of this study is the proportion of subjects with PSMA-positive (identified by H&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging. Because this is an exploratory pilot study, no formal sample size/power calculation is required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be constructed to be within ± 19.0% of the observed proportion of patients with successful imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success proportion of 75%. All estimates from the study will serve as preliminary data (i.e., hypothesis-generating) for future studies.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PSMA Imaging of Localized Prostate Cancer
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Interventional

Injection of study drug followed by PET/CT imaging.

Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.

Followed by prostatectomy

 Drug: 89ZR-DF-IAB2M
injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan

Drug: 68Ga-PSMA-HBED-CC
Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Number of Subjects With PSMA-positive (Prostate-specific Membrane Antigen) "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 89Zr-df-IAB2M PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    The number of subjects whose lesions have been successfully identified through 89Zr-df-IAB2M PET/CT will be ascertained using a combination of the descriptive statistics and lesion-based analysis, which both utilize multiple measurements

  2. The Number of Subjects With PSMA-positive "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    The number of subjects with PSMA-positive (prostate-specific membrane antigen) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 68Ga-PSMA-HBED-CC PET/CT


Secondary Outcome Measures :
  1. The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
  2. The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    Participants underwent 68Ga-PSMA-HBED-CC injection and PET/CT scan (1 to 3 hours after the injection),e performed prior to radical prostatectomy.

  3. The Number of Clinically Significant Lesions Detected by mpMRI [ Time Frame: Up to 30 days pre-prostatectomy ]
    pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions

  4. The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    The Number of Clinically Significant Lesions Detected by mpMRI in subjects who underwent 68Ga-PSMA-HBED-CC injection and PET/CT

  5. The Number of Clinically Significant Lesions Detected by 89Zr-df-IAB2M PET/CT in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT

  6. The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
  7. The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
  8. The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
  9. The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
  10. The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography) [ Time Frame: Up to 30 days pre-prostatectomy ]
    All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events

  11. The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT [ Time Frame: Up to 30 days pre-prostatectomy ]
    All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed localized prostate cancer that are scheduled to undergo radical prostatectomy.
  • Age >18 years.

  • Patients must have laboratory values consistent with eligibility to undergo a radical prostatectomy:

    • creatinine less than or equal to 1.5 X upper limit of normal
    • creatinine clearance > 60 mL/min
  • The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT and the surgical resection used for the study evaluation.
  • Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M administration.
  • Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675451


Locations
Layout table for location information
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Douglas S Scherr, MD Weill Medical College of Cornell University
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
Study Protocol and Statistical Analysis Plan  [PDF] May 31, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03675451    
Other Study ID Numbers: 1311014489
First Posted: September 18, 2018    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: October 14, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
PET/CT
Imaging
Nuclear Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action