NCT04279561

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo 68Ga-PSMA-11 PET/CT
DRUG	Gallium Ga 68 Gozetotide	Given IV
PROCEDURE	Positron Emission Tomography	Undergo 68Ga-PSMA-11 PET/CT

Timeline

• Start date: 2020-04-16
• Primary completion: 2022-09-15
• Completion: 2022-09-15
• First posted: 2020-02-21
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study