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NCT Number: NCT03444844

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Recurrent Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ga-68 P16-093 PET/CT scan

Drug

IV injection followed by PET/CT scanning

Other names: PSMA-93, HBED-CC-PHENOXY-PSMA, PSMA-093, Ga-68-P16-093

Primary outcomes

  1. 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. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Five Eleven Pharma, Inc.

Industry

Collaborators

  • Indiana University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 23, 2018
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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