Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Michael Evans, PhD
Photo of Michael Evans
Michael Evans

Description

Summary

This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Anti-hormone therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.

Official Title

A First-in-Human, Phase I PET Imaging Study of 11C-YJH08, a Selective Glucocorticoid Receptor-Targeting Agent, in Patients With Advanced Solid Tumor Malignancies

Details

PRIMARY OBJECTIVES: I. To determine the feasibility of metastatic lesion detection in enzalutamide/apalutamide-resistant metastatic castration-resistant prostate cancer (mCRPC) using 11C-YJH08 PET. (Cohort A) II. To determine the mean percent change from baseline at the time of progression on enzalutamide or apalutamide in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET on a per-patient and per-lesion basis. (Cohort B) SECONDARY OBJECTIVES: I. To determine the safety and determine average organ uptake of 11C-YJH08. (Cohort A and B) II. To descriptively report the patterns of intra-tumoral uptake of 11C-YJH08 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal. (Cohort A and B) III. To determine whether baseline uptake on 11C-YJH08 PET is associated with subsequent clinical outcomes including objective response rate, progression-free survival, and prostate specific antigen (PSA50) response. (Cohort B) EXPLORATORY OBJECTIVE: I. To determine the association between uptake on 11C-YJH08 PET with glucocorticoid receptor (GR) expression and transcriptional signature scores on paired metastatic tumor biopsies. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients receive 11C-YJH08 intravenously (IV) over 1-2 minutes and 10-60 minutes later, undergo either PET/magnetic resonance imaging (MRI) or PET/computed tomography (CT) over 90 minutes at baseline. ARM II: Patients receive 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline and at time of disease progression. After completion of study treatment, patients are followed up on day 1.

Keywords

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Carcinoma Prostatic Neoplasms Computed Tomography Magnetic Resonance Imaging Positron Emission Tomography 11C-YJH08

Eligibility

You can join if…

Open to males ages 18 years and up

  • COHORT A: Histologically-confirmed progressive metastatic castration resistant prostate cancer with evidence of progression by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) on current enzalutamide or apalutamide treatment at the time of study entry
  • COHORT B: Metastatic castration-resistant prostate cancer with planned treatment with enzalutamide or apalutamide as next line of systemic therapy at the time of study entry. Patients must not have received first dose of enzalutamide or apalutamide prior to baseline 11C-YJH08 PET
  • Patients in Cohort A and B must have serum testosterone level < 50 ng/dL and must remain on luteinizing hormone-releasing hormone (LHRH) analog therapy for the duration of study participation, in the absence of prior bilateral orchiectomy
  • The subject is able and willing to comply with study procedures and provide signed and dated informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Age 18 years or older at the time of study entry
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR estimated creatinine clearance > 50 ml/min
  • Total bilirubin =< 1.5 x ULN
  • Hemoglobin >= 8.0 g/dL
  • Platelet count >= 50,000/microliter
  • Absolute neutrophil count >= 1000/microliter

You CAN'T join if...

  • Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent
  • Concurrent treatment with any dose of systemic glucocorticoids within 7 days prior to cycle 1 day 1 (C1D1)
  • History of adrenal insufficiency requiring use of systemic glucocorticoid replacement
  • History of Cushing's disease or Cushing's syndrome
  • Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures
  • Contra-indication to MRI (e.g. pacemaker placement, severe claustrophobia) (applicable only for patients scheduled for PET/MRI)

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Michael Evans, PhD
    Associate Professor, Radiology. Authored (or co-authored) 71 research publications. Research interests: Cancer · molecular imaging · positron emission tomography · biomarkers · proteomics · organic chemistry · chemical biology · prostate cancer · high grade glioma · oncogenes · androgen receptor · MYC · PI3K · tumor suppressors · signaling pathways · nuclear medicine. · tuberous sclerosis complex

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Michael Evans
ID
NCT04927663
Phase
Phase 1
Study Type
Interventional
Last Updated