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Summary

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

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

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02391025
Lead Scientist
Rahul Aggarwal
Study Type
Interventional
Last Updated
June 1, 2017
I’m interested in this study!