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

NCT03444844 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: IU-1711061247
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Recurrent; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Biochemical recurrent prostate cancer

EXPERIMENTAL

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

Intermediate/High Risk primary prostate cancer

EXPERIMENTAL

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

Interventions

Ga-68 P16-093 PET/CT scan DRUG

IV injection followed by PET/CT scanning

Also known as: PSMA-93, HBED-CC-PHENOXY-PSMA, PSMA-093, Ga-68-P16-093

Biochemical recurrent prostate cancer; Intermediate/High Risk primary prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Five Eleven Pharma, Inc.: lead
• Indiana University: collaborator

Study Sites (1)

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

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

68 Ga-P16-093

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark Green, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: May 10, 2018
• Primary Completion: October 27, 2020
• Study Completion: July 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)