11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Evans
• Collaborators: National Institute of Mental Health (NIMH); U.S. Army Medical Research Acquisition Activity

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)