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Trial record 19 of 278 for:    prostate cancer AND localized | ( Map: United States )

PSMA Imaging of Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03675451
Recruitment Status : Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Proportion 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 imaging [ Time Frame: Up to 10 Weeks ]

    The proportion of subjects whose lesions have been successfully identified will be ascertained using a combination of the descriptive statistics and lesion-based analysis, which both utilize multiple measurements

    Descriptive statistics: Median and inter-quartile range, or mean and standard deviation for age, biopsy Gleason score (1o, 2o, Total), number of cores and positive cores on biopsy, prostate-specific antigen, and Gleason score (1o, 2o, total) and number of lesions and lesion size on prostatectomy pathology

    Lesion-based analysis: SUVmax (maximum standardized uptake value) measurements of 89Zr-df-IAB2M PET/CT (Positron emission tomography-computed tomography) images obtained in tumor and non-tumor regions will be compared. To account for intrapatient correlation of multiple lesions, a linear mixed-effects model with a random intercept will be used to estimate and compare the mean SUVmax values in different regions. P<0.05 will be indicative of a significant difference



Secondary Outcome Measures :
  1. ability of in vivo 89Zr-df-IAb2M PET/CT (Positron emission tomography-computed tomography) to correlate with pathological features [ Time Frame: Up to 10 Weeks ]
    The Wilcoxon rank sum test will be used to compare lesions that were and were not identified on in vivo PET (Positron emission tomography) with respect to lesion size, immunohistochemical PSMA (prostate-specific membrane antigen) staining, and Gleason score (demonstrated by histopathology). This lesion based analysis will be performed in a similar fashion as described above.

  2. 89Zr-df-IAb2M PET/CT (Positron emission tomography-computed tomography) and 68Ga-PSMA-HBED-CC PET/CT (Positron emission tomography-computed tomography) compared to in vivo mpMRI (multiparametric magnetic resonance imaging) [ Time Frame: Up to 10 Weeks ]
    The diagnostic accuracy of 89Zr-df-IAB2M PET/CT Positron emission tomography-computed tomography) and 68Ga-PSMA-HBED-CC PET/CT (Positron emission tomography-computed tomography) imaging in patients with prostate cancer will be compared with that of mpMRI (multiparametric magnetic resonance imaging) imaging by using sector-based analysis. The estimates of patient-specific sensitivity and specificity will be defined as the proportion of true-positive sectors and the proportion of true-negative sectors in each patient. Overall sensitivity and specificity will then be estimated by calculating the mean (and standard error) of these individual-specific estimates across patients. Differences in sensitivity and specificity between modalities will then be evaluated by the Wilcoxon signed-rank test.

  3. Correlation of IAB2M positivity (SUV (standardized uptake value)) and lesion size [ Time Frame: Up to 10 Weeks ]
    The Spearman-rank correlation coefficient will be used to evaluate the association between SUV (standardized uptake value) and size of the lesion

  4. Correlation of IAB2M positivity (SUV (standardized uptake value)) and Gleason pattern (3, 4 and 5) [ Time Frame: Up to 10 Weeks ]
    The Spearman-rank correlation coefficient will be used to evaluate the association between correlate SUV (standardized uptake value) and the histopathologically defined Gleason pattern. The Wilcoxon rank-sum test will also be used to compare SUVmax (standardized uptake value) measurements between lesions with low Gleason score (3+4 or lower) and high Gleason score (4+3 or higher).

  5. Correlation of IAB2M positivity (SUV (standardized uptake value)) and PSA (Prostate-Specific Antigen) [ Time Frame: Up to 10 Weeks ]
    The Spearman-rank correlation coefficient will be used to evaluate the association between SUV (standardized uptake value) and serum PSA levels obtained during screening.

  6. the ability of in vivo 89Zr-df-IAB2M PET/CT (Positron emission tomography-computed tomography) to identify extra-prostatic extension [ Time Frame: Up to 10 Weeks ]
    The Wilcoxon rank-sum test will be used to compare SUVmax (standardized uptake value)measurements of IAB2M-positive extra-prostatic sites between lesions with and without histopathologically confirmed extra-prostatic extension.

  7. the ability of in vivo 89Zr-df-IAB2M PET/CT (Positron emission tomography-computed tomography) to identify occult lymph node involvement [ Time Frame: Up to 10 Weeks ]
    The Wilcoxon rank-sum test will be used to compare SUVmax (standardized uptake value) measurements of IAb2M-positive lymph nodes between patients with and without histopathologically confirmed lymph node involvement.

  8. Incidence of Treatment-Emergent Adverse Events following 89ZR-DF-IAB2M PET/CT (Positron emission tomography-computed tomography) [ Time Frame: Up to 10 Weeks ]

    There are no known contraindications for 89Zr-df-IAB2M. No drug related adverse events were reported in the Phase I study. Subjects will be monitored for safety for one hour following the infusion.

    The 14-day sterility testing will not be completed at the time of 89Zr-df-IAB2M infusion. The 89Zr-df-IAB2M dose will be released based on the controlled process along with a history of sterile lots. Sterility tests will be evaluated during the 14-day period.

    All adverse events will be recorded on a patient specific adverse event log. The AE log will be maintained by the research staff and kept in the patient's research chart.

    Changes in the the following labs RFT (Renal Function Test), LFT (Liver Function Test), CBC (Complete Blood Count), CMP (comprehensive metabolic panel) will be examined, including following the parameters for toxicity throughout study participation


  9. Incidence of Treatment-Emergent Adverse Events following 68Ga-PSMA-HBED-CC imaging [ Time Frame: Up to 10 Weeks ]

    There are no known contraindications for 68Ga-PSMA-HBED-CC. Because of the potential for infusion or allergic reaction, the subject will be monitored for safety for one hour following the infusion.

    All adverse events will be recorded on a patient specific adverse event log. The AE log will be maintained by the research staff and kept in the patient's research chart.

    Changes in the the following labs RFT (Renal Function Test), LFT (Liver Function Test), CBC (Complete Blood Count), CMP (comprehensive metabolic panel) will be examined, including following the parameters for toxicity throughout study participation.




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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.

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
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Douglas S Scherr, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03675451     History of Changes
Other Study ID Numbers: 1311014489
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Edetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action