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

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

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.

Study Overview

• Status: Terminated
• Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8
• Intervention / Treatment: Drug: Gallium Ga 68 Gozetotide; Procedure: Computed Tomography; Procedure: Positron Emission Tomography

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).

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically proven prostate cancer
• Know metastatic disease on previous imaging, or PSA value ⩾ 1 ng/ml;
• Castration resistant disease with confirmed testosterone level =< 50 ng/ml under prior first-line androgen deprivation therapy (ADT)
• New planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide
• Willingness to undergo ARSI throughout the duration of the study as prescribed by the treating uro-oncologist
• Stated willingness to comply with continuation of ARSI treatment for the duration of the study
• Provision of signed and dated informed consent form

Exclusion Criteria:

• Inability to provide written informed consent
• Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
• Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
• A baseline superscan pattern on bone scan
• Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Drug: Gallium Ga 68 Gozetotide; Given IV; Other Names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC; (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; 68Ga-DKFZ-PSMA-11; 68Ga-HBED-CC-PSMA; 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-PSMA; 68Ga-PSMA-11; 68Ga-PSMA-HBED-CC; [68Ga] Prostate-specific Membrane Antigen 11; [68Ga]GaPSMA-11; Ga PSMA; Ga-68 labeled DKFZ-PSMA-11; Ga-68 labeled PSMA-11; GA-68 PSMA-11; Gallium Ga 68 PSMA-11; Gallium Ga 68-labeled PSMA-11; GALLIUM GA-68 GOZETOTIDE; Gallium-68 PSMA; Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; GaPSMA; PSMA-HBED-CC GA-68; Procedure: Computed Tomography; Undergo 68Ga-PSMA-11 PET/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Positron Emission Tomography; Undergo 68Ga-PSMA-11 PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Baseline, assessed up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate specific antigen (PSA) kinetics under ARSI	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.	Baseline, assessed up to 1 year
Biochemical progression free survival (bPFS)	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.	Up to 1 year
Changes in lesion size on cross sectional imaging under ARSI	Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.	Up to 1 year
Changes in staging (PSMA miTNM PROMISE criteria) under ARSI	Will utilize mixed effects regression models to evaluate the change in staging over time.	Up to 1 year
Incidence of adverse events	Assessed by Common Terminology Criteria for Adverse Events 4.03.	Up to 1 year

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Carcinoma; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Edetic Acid; Gallium 68 PSMA-11
• Other Study ID Numbers: 19-002024; NCI-2020-00239 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No