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11C-YJH08 for Prostate Cancer

Phase 1

Recruiting

Led By Rahul Aggarwal, MD

Research Sponsored by Michael Evans

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

COHORT B: Metastatic castration-resistant prostate cancer with planned treatment with enzalutamide, apalutamide, 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 darolutamide prior to baseline 11C-YJH08 PET

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing if a new imaging method can help detect if a particular cell receptor is increasing in tumors during treatment. If successful, it could lead to more successful therapies using a cell receptor antagonist.

Who is the study for?

This trial is for adults with metastatic castration-resistant prostate cancer, currently on or planning to start treatments like enzalutamide. They must have a good performance status, controlled testosterone levels (if not surgically removed), and normal organ function. Excluded are those with certain medical conditions, recent glucocorticoid use, adrenal insufficiency, inability to consent, or contraindications to MRI.Check my eligibility

What is being tested?

The study tests if PET imaging using the radiotracer 11C-YJH08 can better detect glucocorticoid receptor expression in tumors of patients whose prostate cancer has spread. This could help identify resistance to hormone therapies and improve treatment strategies.See study design

What are the potential side effects?

As this trial focuses on imaging techniques rather than drug interventions, side effects may include discomfort from lying still during scans and potential reactions to contrast agents used in CT/MRI scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have prostate cancer resistant to standard treatment and haven't started new medication yet.

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I am 18 years old or older.

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My kidney function, measured by creatinine levels, is within the normal range.

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My prostate cancer is worsening despite current treatment with enzalutamide, apalutamide, or darolutamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET per-lesion (Cohort B only)

Mean percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave on paired 11C-YJH08 PET per-patient basis (Cohort B only)

Sensitivity of 11C-YJH08 PET in metastatic lesion detection (Cohort A only)

Secondary outcome measures

Association between baseline uptake on 11C-YJH08 PET and objective response rate (Cohort B only)

Positron-Emission Tomography

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: 11C-YJH08 with additional PET/MRI, PET/CT at progressionExperimental Treatment4 Interventions

Patients receive approximately 20 mCi of 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.

Group II: Cohort A: 11C-YJH08 with PET/MRI or PET/CTExperimental Treatment4 Interventions

Patients receive approximately 20 millicurie (mCi) of 11C-YJH08 IV over 1-2 minutes and 10-60 minutes later, undergo either PET/MRI or PET/CT over 90 minutes at baseline.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720