Effect of Androgen Receptor Signaling Inhibitors on 68Ga-PSMA-11 PET/CT Imaging in Patients With Metastatic Castration-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04279561|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8||Procedure: Computed Tomography Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography||Early Phase 1|
I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI).
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.
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 and 2 weeks after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Novel Androgen Receptor Signaling Inhibitors on PSMA PET Signal Intensity in Patients With Metastatic Castrate-Resistant Prostate Cancer: A Prospective Exploratory Study|
|Estimated Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||June 15, 2021|
|Estimated Study Completion Date :||June 15, 2022|
Experimental: Diagnostic (68GA-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV. After 50-100 minutes, patients undergo PET/CT over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 and 2 weeks after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Procedure: Computed Tomography
Undergo 68Ga-PSMA-11 PET/CT
Drug: Gallium Ga 68-labeled PSMA-11
Procedure: Positron Emission Tomography
Undergo 68Ga-PSMA-11 PET/CT
- Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI) [ Time Frame: Baseline, assessed up to 1 year ]Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
- Prostate specific antigen (PSA) kinetics under ARSI [ Time Frame: Baseline, assessed up to 1 year ]Comparison of 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes over time to PSA kinetics under ARSI. Will use mixed effects regression models to correlate the PSMA and PSA time trends. These models will include the effect of time and the PSMA by time interaction effect.
- Biochemical progression free survival (bPFS) [ Time Frame: Up to 1 year ]Correlation between 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes and time of bPFS under ARSI. Will utilize Cox-proportional hazards regression models. PSMA results will be treated as a time dependent covariate in these models.
- Changes in lesion size on cross sectional imaging under ARSI [ Time Frame: Up to 1 year ]Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.
- Changes in staging (PSMA miTNM PROMISE criteria) under ARSI [ Time Frame: Up to 1 year ]Will utilize mixed effects regression models to evaluate the change in staging over time.
- Incidence of adverse events [ Time Frame: Up to 1 year ]Assessed by Common Terminology Criteria for Adverse Events 4.03.
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): NCT04279561
|Contact: Rejah Alano||310 206-7372||RMAlano@mednet.ucla.edu|
|Contact: Kiara Booker Adame||310 206-7372||KMBooker@mednet.ucla.edu|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Contact: Stephanie Lira 310-206-7372 StephanieLira@mednet.ucla.edu|
|Contact: Rajah Alano 310 206-7372 RMAlano@mednet.ucla.edu|
|Principal Investigator: Jeremie Calais, MD|
|Principal Investigator:||Jeremie Calais, MD||UCLA / Jonsson Comprehensive Cancer Center|