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

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: Active, not recruiting
• Conditions: Prostate Cancer; Prostate Cancer Recurrent
• Intervention / Treatment: Drug: Ga-68 P16-093 PET/CT scan

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
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.	4 months
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.	2-60 days following PET/CT scan

Collaborators and Investigators

• Sponsor: Five Eleven Pharma, Inc.
• Collaborators: Indiana University
• Investigators: Principal Investigator: Mark Green, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): October 27, 2020
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID 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