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Spots Global Cancer Trial Database for Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

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Trial Identification

Brief Title: Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Castration-Resistant Prostate Cancer

Official Title: Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study

Study ID: NCT04279561

Study Description

Brief Summary: This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.

Detailed Description: PRIMARY OBJECTIVE: I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI). SECONDARY OBJECTIVES: I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics. II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation \[PROMISE\] criteria) under ARSI. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Contact Details

Name: Jeremie Calais

Affiliation: UCLA / Jonsson Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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