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Gallium-68 Citrate PET Used in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02391025
Recruitment Status : Active, not recruiting
First Posted : March 18, 2015
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Rahul Aggarwal, University of California, San Francisco

Brief 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 NCT02432001 (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 NCT02432001 (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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Gallium-68 citrate PET Procedure: Positron Emission Tomography (PET) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 Citrate PET To Detect MYC Amplification in Metastatic Castrate Resistant Prostate Cancer
Actual Study Start Date : May 28, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Gallium-68 citrate Drug: Gallium-68 citrate PET
Injection of Gallium-68 citrate followed by PET imaging

Procedure: Positron Emission Tomography (PET)



Primary Outcome Measures :
  1. SUVmax [ Time Frame: Day 1 ]
    Mean maximum Standardized Uptake Value (SUV) across all metastatic lesions per patient.

  2. SUVmax-ave [ Time Frame: Day 1 ]
    Mean maximum Standardized Uptake Value (SUV) across all metastatic lesions across all patients.


Secondary Outcome Measures :
  1. Correlation between SUVmax and MYC gene expression [ Time Frame: Day 1 ]
    For patients 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.

  2. Correlation between SUVmax and transferrin receptor gene expression [ Time Frame: Day 1 ]
    For patients 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.

  3. Mean SUVmax-ave percent change from baseline [ Time Frame: Within 12 weeks of baseline Gallium-68 Citrate PET ]
    Mean SUVmax-ave percent change from baseline among patients who undergo optional follow up Gallium-68 Citrate PET following treatment initiation with systemic therapy for Metastatic Castration-Resistant Prostate Cancer (mCRCP)

  4. Sensitivity of gallium citrate PET [ Time Frame: Day 1 ]
    Compared to bone scan

  5. Specificity of gallium citrate PET [ Time Frame: Day 1 ]
    Compared to bone scan



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391025


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Rahul Aggarwal
United States Department of Defense
Investigators
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Principal Investigator: Rahul Aggarwal, MD University of California, San Francisco
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Responsible Party: Rahul Aggarwal, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02391025    
Other Study ID Numbers: 145512
NCI-2017-01773 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rahul Aggarwal, University of California, San Francisco:
Metastatic
Prostate Cancer
Castrate Resistant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases