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

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer Recurrent; Prostate Cancer
• Interventions: Drug: Ga-68 P16-093 PET/CT scan

• Registration Number: NCT03444844
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-23
• Study Start: 2018-05-10
• Primary Completion: 2020-10-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biochemical recurrent prostate cancer	Ga-68 P16-093 PET/CT scan	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.
Intermediate/High Risk primary prostate cancer	Ga-68 P16-093 PET/CT 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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Ga-68-P16-093 in primary PCa	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.
The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions	4 months	Change in management will be based on physician questionnaires including confirmation of actual treatment.
Sensitivity of Ga-68-P16-093 in BCR	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.

Trial Locations

Locations (1)

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States