Gallium-68 Citrate PET Used in Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391025
• Other study ID #: 145512
• Secondary ID: NCI-2017-01773
• Status: Completed
• Phase: Early Phase 1
• Start date: May 28, 2015
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Gallium-68 citrate
Given via IV at time of imaging

Procedure:
• Positron Emission Tomography (PET)
Imaging procedure

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Rahul Aggarwal	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day of imaging (1 day)
Primary	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.	Day of imaging (1 day)
Secondary	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.	Day of imaging (1 day)
Secondary	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.	Day of imaging (1 day)
Secondary	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.	Up to 12 weeks
Secondary	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.	Day of imaging (1 day)
Secondary	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.	Day of imaging (1 day)
Secondary	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.	Day of imaging (1 day)
Secondary	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.	Up to 12 weeks