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Gallium-68 Citrate PET Used in Prostate Cancer

Sponsor
Rahul Aggarwal (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02391025
Collaborator
United States Department of Defense (U.S. Fed)
39
Enrollment
1
Location
1
Arm
91.1
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Gallium-68 citrate PET
  • Procedure: Positron Emission Tomography (PET)
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. SUVmax [Day 1]

    Mean maximum Standardized Uptake Value (SUV) across all metastatic lesions per patient.

  2. SUVmax-ave [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 [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 [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 [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 [Day 1]

    Compared to bone scan

  5. Specificity of gallium citrate PET [Day 1]

    Compared to bone scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • Rahul Aggarwal
  • United States Department of Defense

Investigators

  • Principal Investigator: Rahul Aggarwal, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rahul Aggarwal, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02391025
Other Study ID Numbers:
  • 145512
  • NCI-2017-01773
First Posted:
Mar 18, 2015
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rahul Aggarwal, Assistant Clinical Professor, University of California, San Francisco
Metastatic
Prostate Cancer
Castrate Resistant
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jun 24, 2022