Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais (ucla)

Description

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.

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

Details

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 and 2 weeks after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).

Keywords

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 Carcinoma Prostatic Neoplasms Edetic Acid Computed Tomography Gallium Ga 68-labeled PSMA-11 Positron Emission Tomography

Eligibility

You can join if…

Open to males ages 18 years and up

  • Histologically proven prostate cancer
  • Metastatic disease: at least one known metastatic lesion
  • 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 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

You CAN'T join if...

  • 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 or prior 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

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04279561
Phase
Phase 1
Study Type
Interventional
Last Updated