Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Rahul Aggarwal
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Mean maximum Standardized Uptake Value (SUVmax)
Study Overview
Brief Summary
This is a single center, pilot, cross-sectional imaging study investigating the use of gallium-68 citrate PET in participants 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 participants 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.
Detailed Description
Primary Objective:
I. To determine the association between maximum average of standard uptake value (SUVmax-ave) of target metastatic lesions on gallium-68 citrate PET with MYC amplification determined from analysis of circulating tumor DNA.
Secondary Objectives:
I. To determine the accuracy rate, sensitivity, specificity of gallium citrate PET in the detection of metastatic lesions as compared to standard staging scans including cross-sectional imaging of the abdomen/pelvis and whole body bone scan.
II. To determine the optimal dose of gallium-68 citrate and timing of scan post-injection to maximize tumor-to-background signal.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male participants with histologically confirmed prostate cancer
- •Participants 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 participants 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 participants planning to be imaged on PET/ Magnetic resonance imaging(MRI) scanner)
- •Active infection within 14 days of study enrollment
- •For participants 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.
Arms & Interventions
Gallium-68 citrate, PET
Participants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan.
Intervention: Gallium-68 citrate (Drug)
Gallium-68 citrate, PET
Participants will receive a single scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment received outside this study that will be completed within 12 weeks of baseline scan.
Intervention: Positron Emission Tomography (PET) (Procedure)
Outcomes
Primary Outcomes
Mean maximum Standardized Uptake Value (SUVmax)
Time Frame: Day of imaging (1 day)
The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported.
Mean maximum Standardized Uptake Value (SUVmax-ave)
Time Frame: Day of imaging (1 day)
The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported.
Secondary Outcomes
- Correlation between SUVmax and MYC gene expression(Day of imaging (1 day))
- Correlation between SUVmax and transferrin receptor gene expression(Day of imaging (1 day))
- Mean SUVmax-ave percent change from baseline(Up to 12 weeks)
- Sensitivity of gallium-68 PET(Day of imaging (1 day))
- Specificity of gallium-68 PET(Day of imaging (1 day))
- Positive predictive value (PPV) of gallium-68 PET(Day of imaging (1 day))
- Number of participants with reported treatment-emergent adverse events(Up to 12 weeks)
Investigators
Rahul Aggarwal
Assistant Clinical Professor
University of California, San Francisco