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Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer With Biochemical Recurrence

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444844
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Five Eleven Pharma, Inc.

Brief Summary:
Initial performance of Ga-68-P16-093 in prostate cancer patients including dosimetry and preliminary efficacy evaluation in BCR patients, and correlation of Ga-68-P16-093 uptake with tissue histopathology in intermediate to high risk primary prostate cancer patients.

Condition or disease Intervention/treatment Phase
Prostate Cancer Recurrent Prostate Cancer Drug: Ga-68 P16-093 PET/CT scan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer With Biochemical Recurrence
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Biochemical recurrent prostate cancer

IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by whole body PET/CT scanning (pelvis to shoulders) for ~ 60 min (~150 min for first 10 patients/dosimetry) starting immediately after injection.

A contrast CT scan follows PET scan.

Drug: Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning
Other Names:
  • PSMA-93
  • HBED-CC-PHENOXY-PSMA
  • PSMA-093
  • Ga-68-P16-093

Experimental: Intermediate/High Risk primary prostate cancer
IV injection of 2 - 6 mCi of Ga-68 P16-093 followed by list mode PET/CT scanning using a fixed FOV including the pelvis area for ~ 50 min.
Drug: Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning
Other Names:
  • PSMA-93
  • HBED-CC-PHENOXY-PSMA
  • PSMA-093
  • Ga-68-P16-093




Primary Outcome Measures :
  1. Sensitivity of Ga-68-P16-093 in BCR [ Time Frame: 2 weeks ]
    We will compare the number and location of metastatic lesions apparently detected by 68Ga-P16-093 with the number and location of lesions detected by standard-of-care imaging. Sensitivity of the 68Ga-P16-093 PET procedure will be estimated based on the number of subjects in whom a site of disease is identified by the imaging procedure. Scans will also be reconstructed summing passes 1-5, passes 2-5, passes 3-5, and passes 1-2 to assess how image quality varies with chosen framing.

  2. The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions [ Time Frame: 4 months ]
    Change in management will be based on physician questionnaires including confirmation of actual treatment.

  3. Sensitivity and Specificity of Ga-68-P16-093 in primary PCa [ Time Frame: 2-60 days following PET/CT scan ]
    We will estimate the sensitivity and specificity of the 68Ga-P16-093 PET imaging by comparing the PET SUV values and whole-mount pathology findings on a sextant basis (6 sextants per subject x 10 subjects). Images will be evaluated from ~ 5 min to 60 minutes of scanning in 5-10 minutes up to 45 min frames.



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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 (Cohort 1):

  • Male ≥ 18 years of age
  • Prostate cancer patients presenting with rising PSA after radical prostatectomy for treatment if primary disease.
  • PSA ≥ 0.2 ng/mL
  • Patients must give informed consent for the research study, and agree to allow investigator access to clinical results following treatment plan implementation such as description of the treatment plan and PSA values following implementation of treatment plan as part of standard care, typically determined 3-4 months after treatment.

Inclusion Criteria (Cohort 2):

  • Male ≥ 18 years of age
  • Histologically confirmed prostate cancer with following Gleason scoring at biopsy:

    • Gleason ≥ 4+3 OR
    • Gleason 3+4 with >30% pattern 4 or ≥3 cores positive
  • Scheduled for radical prostatectomy (expected to occur within 60-days of scanning)
  • Patients must give informed consent for the research study, and agree to allow investigator access to the clinical results such as SOC imaging (mpMRI, e.g.) for surgical planning if done, or biopsy data following prostatectomy including lymph node dissection biopsy data, if available.

Exclusion Criteria (Cohorts 1& 2):

  • Inability to give informed consent.
  • Patient is unable to tolerate remaining still on the bed of the PET camera, due to physical limitations or claustrophobia.
  • Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Clinical Investigators, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

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): NCT03444844


Contacts
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Contact: Courtney Dohondt 317-274-1791 ORI@iupui.edu

Locations
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United States, Indiana
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mark Green, Ph.D         
Sponsors and Collaborators
Five Eleven Pharma, Inc.
Indiana University
Investigators
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Principal Investigator: Mark Green, PhD Indiana University School of Medicine
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Responsible Party: Five Eleven Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03444844    
Other Study ID Numbers: IU-1711061247
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes