Prostate Cancer Clinical Trial
11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer
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.
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)
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)
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.
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, apalutamide, or darolutamide treatment at the time of study entry
COHORT B: Metastatic castration-resistant prostate cancer with planned treatment with enzalutamide, apalutamide, or or darolutamide as next line of systemic therapy at the time of study entry. Patients must not have received first dose of enzalutamide, apalutamide, or or darolutamide 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. If testosterone level is pending at the time of baseline Positron Emission Tomography (PET), it is permissible to proceed with baseline PET, provided there is documentation of continuous Luteinizing hormone-releasing hormone (LHRH) analog treatment in the preceding 3 months.
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
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)
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