Clinical trial NCT03444844: Biodistribution and Dosimetry of Ga-68 P16-093 in Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer Recurrent
Prostate Cancer
Lead sponsor: Five Eleven Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Indiana University
First posted: 2018-02-23
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Ga-68-P16-093 in BCR
timeFrame: 2 weeks
measure: The proportion of patients for whom Ga-18-P16-093 PET/CT changes treatment through detection of lesions
timeFrame: 4 months
measure: Sensitivity and Specificity of Ga-68-P16-093 in primary PCa
timeFrame: 2-60 days following PET/CT scan
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Mark Green, PhD
role: PRINCIPAL_INVESTIGATOR
References: