Overview

Gallium-68 Citrate PET Used in Prostate Cancer

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
Male
Summary
This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol NCT02432001 (CC#125519). The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol NCT02432001 (CC#125519), with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rahul Aggarwal
Collaborator:
United States Department of Defense
Criteria
Inclusion Criteria:

- Male patients with histologically confirmed prostate cancer

- Patients must have castrate levels of testosterone (< 50 ng/dL) on Luteinizing
hormone-releasing hormone (LHRH) analogue or have had prior bilateral orchiectomy,
with evidence of castration-resistant disease by Prostate Cancer Clinical Trials
Working Group 2 (PCWG2) criteria

- Age 18 years or older at the time of study entry

- Minimum of at least three discrete metastatic lesions in the bone and/or soft tissue
amenable to whole body Positron Emission Tomography (PET) imaging per the judgment of
study radiologist

For patients who undergo optional metastatic tumor biopsy following completion of gallium
citrate PET:

- Presence of one or more metastases by standard radiographic scans that is safely
accessible to tumor biopsy in the judgment of treating clinician and/or Interventional
Radiology

Exclusion Criteria:

- Contra-indications to MRI, including permanent pacemaker, implantable device, aneurysm
clip, or severe claustrophobia (for patients planning to be imaged on PET/ Magnetic
resonance imaging(MRI) scanner)

- Active infection within 14 days of study enrollment

For patients who undergo optional metastatic tumor biopsy following completion of gallium
citrate PET:

- History of radiation therapy to the target metastatic lesion selected for tumor biopsy

- Contra-indication to biopsy including uncontrolled bleeding diathesis.

- Platelets >75,000/μl and prothrombin time (PT) or international normalized ratio (INR)
and a partial prothrombin time (PTT) < 1.5 times the institutional upper limit of
normal (ULN) within 14 days prior to biopsy.