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Gallium-68 Citrate PET Used in Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gallium-68 citrate
Positron Emission Tomography (PET)
Sponsored by
Rahul Aggarwal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostatic Neoplasms focused on measuring Metastatic, Prostate Cancer, Castrate Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gallium-68 citrate, PET

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean maximum Standardized Uptake Value (SUVmax)
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)
The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported.

Secondary Outcome Measures

Correlation between SUVmax and MYC gene expression
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and MYC gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Correlation between SUVmax and transferrin receptor gene expression
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and transferrin receptor gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Mean SUVmax-ave percent change from baseline
For participants who undergo optional follow up gallium-68 citrate PET scan, the mean percent change from baseline in SUVmax-ave will be descriptively reported.
Sensitivity of gallium-68 PET
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Specificity of gallium-68 PET
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the specificity of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Positive predictive value (PPV) of gallium-68 PET
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the positive predictive value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Number of participants with reported treatment-emergent adverse events
The frequency and severity of adverse events following gallium-68 citrate injection will be descriptively reported, using CTCAE version 4.03.

Full Information

First Posted
March 4, 2015
Last Updated
June 15, 2023
Sponsor
Rahul Aggarwal
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02391025
Brief Title
Gallium-68 Citrate PET Used in Prostate Cancer
Official Title
Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2015 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rahul Aggarwal
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. III. To characterize the safety profile of gallium-68 citrate. Outline: The study will involve gallium-68 PET scan obtained on a single day, followed by optional tumor biopsy within 6 weeks of gallium scan. There will be optional follow up gallium-68 citrate PET scan to assess response to treatment that will be completed within 12 weeks of baseline gallium citrate PET.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Metastatic, Prostate Cancer, Castrate Resistant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gallium-68 citrate, PET
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Gallium-68 citrate
Other Intervention Name(s)
Gallium-68 (8^Ga) citrate, Ga-68 citrate
Intervention Description
Given via IV at time of imaging
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Other Intervention Name(s)
PET Scan
Intervention Description
Imaging procedure
Primary Outcome Measure Information:
Title
Mean maximum Standardized Uptake Value (SUVmax)
Description
The mean and standard deviation of SUVmax of gallium-68 citrate (across all metastatic lesions per participant) will be reported.
Time Frame
Day of imaging (1 day)
Title
Mean maximum Standardized Uptake Value (SUVmax-ave)
Description
The mean and standard deviation of SUVmax-ave of gallium-68 citrate across all participants in the study cohort will be descriptively reported.
Time Frame
Day of imaging (1 day)
Secondary Outcome Measure Information:
Title
Correlation between SUVmax and MYC gene expression
Description
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and MYC gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Time Frame
Day of imaging (1 day)
Title
Correlation between SUVmax and transferrin receptor gene expression
Description
For participants who undergo optional tumor biopsy, with evaluable RNA sequencing data: Correlation between SUVmax on Gallium-68 Citrate PET and transferrin receptor gene expression level, reported as the Pearson correlation coefficient. The coefficient correlation has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Time Frame
Day of imaging (1 day)
Title
Mean SUVmax-ave percent change from baseline
Description
For participants who undergo optional follow up gallium-68 citrate PET scan, the mean percent change from baseline in SUVmax-ave will be descriptively reported.
Time Frame
Up to 12 weeks
Title
Sensitivity of gallium-68 PET
Description
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the sensitivity value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Time Frame
Day of imaging (1 day)
Title
Specificity of gallium-68 PET
Description
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the specificity of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Time Frame
Day of imaging (1 day)
Title
Positive predictive value (PPV) of gallium-68 PET
Description
Using as a cut-off to define a positive lesion on gallium-68 citrate PET as a lesion with SUV at least 1.5 times higher than mediastinal blood pool, the positive predictive value of gallium-68 PET will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including CT or MRI of the chest/abdomen/pelvis and whole body bone scan.
Time Frame
Day of imaging (1 day)
Title
Number of participants with reported treatment-emergent adverse events
Description
The frequency and severity of adverse events following gallium-68 citrate injection will be descriptively reported, using CTCAE version 4.03.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahul Aggarwal, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Gallium-68 Citrate PET Used in Prostate Cancer

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