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

Five Eleven Pharma

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Prostate Cancer Recurrent; Prostate Cancer

Treatments: Drug: Ga-68 P16-093 PET/CT scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03444844

IU-1711061247

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Biochemical recurrent prostate cancer

Experimental group

Description:

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.

Treatment:

Drug: Ga-68 P16-093 PET/CT scan

Intermediate/High Risk primary prostate cancer

Experimental group

Description:

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.

Treatment:

Drug: Ga-68 P16-093 PET/CT scan