Biodistribution/Reproducibility Ga-68 PSMA-HBED-CC

• Status: Enrolling by invitation
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this Radioactive Drug Research Committee (RDRC) study is to collect initial data regarding biodistribution, reproducibility, and dosimetry for the radiotracer Ga-68 PSMA-HBED-CC, an agent which may be useful for the early detection of metastatic prostate cancer. Investigators will use a test and re-test design in all patients to determine reproducibility of lesion detection and signal intensity, and will include dynamic imaging in some patients for the purposes of dosimetry. Patients with known metastatic prostate cancer will be recruited and imaged on two occasions within the course of 15 days.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janet Pollard; University of Iowa
• Treatments: Edetic Acid; N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid

Criteria

There will be no control group. For the study group the following inclusion and exclusion criteria will be followed.

INCLUSION CRITERIA

• Male

• Aged ≥ 18 years

• Histological diagnosis of adenocarcinoma of the prostate OR have a clinical diagnosis of prostate cancer and on active therapy or have received treatment for prostate cancer.

• Multifocal metastatic disease in either castrate sensitive or castrate resistant patients.

• May or may not be on hormonal therapy, chemotherapy, or radium therapy.

• If on hormonal therapy or chemotherapy, must be on it for at least 3 months.

• No plans to undergo prostate cancer therapy administration (with hormone therapy, chemotherapy, radium therapy, external radiation) between the two study exams.

• At least 2 metastatic soft tissue or bone lesions identified on conventional imaging (CT, MRI or bone scan).

• Karnofsky performance status of ≥ 50 (or ECOG/WHO equivalent)

• Ability to understand and willingness to sign a consent document.

EXCLUSION CRITERIA

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Physical limitation that would limit compliance with the study requirements

• Current enrollment in a therapeutic clinical trial