Gallium-68 Citrate PET Used in Prostate Cancer

NCT02391025 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 145512NCI-2017-01773
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Metastatic; Prostate Cancer; Castrate Resistant

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• 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)

Study Arms (1)

Gallium-68 citrate, PET

EXPERIMENTAL

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.

Drug: Gallium-68 citrate; Procedure: Positron Emission Tomography (PET)

Interventions

Gallium-68 citrate DRUG

Given via IV at time of imaging

Also known as: Gallium-68 (8^Ga) citrate, Ga-68 citrate

Gallium-68 citrate, PET

Positron Emission Tomography (PET) PROCEDURE

Imaging procedure

Also known as: PET Scan

Gallium-68 citrate, PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rahul Aggarwal: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

gallium citrate; Gallium-68; Citric Acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rahul Aggarwal, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 18, 2015
• Study Start: May 28, 2015
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)