Summary

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

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 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 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 Gallium citrate Gallium-68 citrate 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 LHRH analogue or have had prior orchiectomy.
  • Presence of one or more metastases by standard radiographic scans including cross-sectional imaging of the chest/abdomen/pelvis and whole body bone scan that is safely accessible to tumor biopsy in the judgment of treating clinician and/or Interventional Radiology
  • Evidence of disease progression by PCWG2 criteria during or within 4 weeks following treatment discontinuation with potent androgen signaling inhibitor, including abiraterone, enzalutamide, ARN-509, or a combination.
  • Patients must be either receiving or within 4 weeks of discontinuation of androgen signaling inhibitor at the time of PET imaging and tumor biopsy.
  • Age 18 years or older at the time of study entry
  • Platelets >75,000/μl and PT or INR and a PTT < 1.5 times the institutional ULN within 14 days prior to biopsy.

You CAN'T join if...

  • Intervening systemic therapy between discontinuation of androgen signaling inhibitor and planned date 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.
  • Active infection within 14 days of study enrollment
  • Contraindications for MRI (for patients undergoing PET/MR study), including presence of pacemaker, aneurysm clip, implanted device, or severe claustrophobia

Location

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States

Lead Scientist

  • Rahul Aggarwal
    Associate Professor, Medicine. Authored (or co-authored) 42 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02391025
Study Type
Interventional
Last Updated