Summary

for males ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Rahul Aggarwal, MD

Description

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.

Official Title

Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer

Keywords

Prostatic Neoplasms Metastatic Prostate Cancer Castrate Resistant Citric Acid Sodium Citrate Gallium citrate Gallium-68 citrate PET Positron Emission Tomography (PET) Gallium-68 citrate

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

  • Rahul Aggarwal, MD
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer. I serve as the Co-Leader for the GU Medical Oncology program at UCSF.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rahul Aggarwal
ID
NCT02391025
Phase
Phase 1
Study Type
Interventional
Last Updated