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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03444844
• Other study ID #: IU-1711061247
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 10, 2018
• Est. completion date: July 2022

Study information

• Verified date: April 2022
• Source: Five Eleven Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

Drug:
• Ga-68 P16-093 PET/CT scan
IV injection followed by PET/CT scanning

Locations

Country	Name	City	State
United States	Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Five Eleven Pharma, Inc.	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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