Spots Global Cancer Trial Database for Gallium-68 Citrate PET Used in Prostate Cancer

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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