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

Primary Purpose

Prostate Cancer Recurrent, Prostate Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ga-68 P16-093 PET/CT scan
Sponsored by
Five Eleven Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer Recurrent

Eligibility Criteria

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

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

Sites / Locations

  • Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Biochemical recurrent prostate cancer

Intermediate/High Risk primary prostate cancer

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sensitivity of Ga-68-P16-093 in BCR
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.
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
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.

Secondary Outcome Measures

Full Information

First Posted
February 19, 2018
Last Updated
April 29, 2022
Sponsor
Five Eleven Pharma, Inc.
Collaborators
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03444844
Brief Title
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
Official Title
Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Five Eleven Pharma, Inc.
Collaborators
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biochemical recurrent prostate cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Intermediate/High Risk primary prostate cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ga-68 P16-093 PET/CT scan
Other Intervention Name(s)
PSMA-93, HBED-CC-PHENOXY-PSMA, PSMA-093, Ga-68-P16-093
Intervention Description
IV injection followed by PET/CT scanning
Primary Outcome Measure Information:
Title
Sensitivity of Ga-68-P16-093 in BCR
Description
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.
Time Frame
2 weeks
Title
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
Description
Change in management will be based on physician questionnaires including confirmation of actual treatment.
Time Frame
4 months
Title
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
Description
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.
Time Frame
2-60 days following PET/CT scan

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Green, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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

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