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

April 29, 2022 updated by: Five Eleven Pharma, Inc.

Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer Patients With Intermediate/High Risk Primary Disease or Biochemical Recurrence After Treatment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks
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.
4 months
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.
2-60 days following PET/CT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Five Eleven Pharma, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indiana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Green, PhD, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IU-1711061247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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