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PET Imaging for Cancer

Phase 1

Recruiting

Led By Rahul Aggarwal, MD

Research Sponsored by Rahul Aggarwal

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

Must not have

Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent

History of adrenal insufficiency requiring use of systemic glucocorticoid replacement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give informed consent due to my age, health, or mental condition.

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I take steroids for adrenal insufficiency.

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I haven't taken any steroids in the week before starting the trial.

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I have a history of Cushing's disease or syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median percent change from baseline at the time of progression in standardized uptake value (SUV)max-ave (Cohort B and C only)

Median percent change from baseline in standardized uptake value (SUV)max (Cohort B and C only)

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

Secondary study objectives

Association between baseline uptake on 11C-YJH08 PET and clinical benefit rate (Cohort B & C only)

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

Association between baseline uptake on 11C-YJH08 PET with prostate specific antigen (PSA50) response (Cohort B only )

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: Solid Tumor MalignancyExperimental Treatment5 Interventions

Participants with any solid tumor malignancies other than prostate adenocarcinoma with one or more metastases on conventional imaging will 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 optional repeat scan at the time of progression.

Group II: Cohort B: Metastatic CRPCExperimental Treatment5 Interventions

Participants with metastatic CRPC will 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 optional repeat scan at the time of progression.

Group III: Cohort A: Any Solid Tumor (Dosimetry Cohort)Experimental Treatment5 Interventions

Participants with any solid tumor malignancy with evidence of one or more metastases will 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

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

0 / 9Eligibility criteria met

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Who is running the clinical trial?

Rahul AggarwalLead Sponsor

12 Previous Clinical Trials

520 Total Patients Enrolled

7 Trials studying Prostate Cancer

278 Patients Enrolled for Prostate Cancer

Michael EvansLead Sponsor

U.S. Army Medical Research Acquisition ActivityFED

23 Previous Clinical Trials

8,391 Total Patients Enrolled

5 Trials studying Prostate Cancer

181 Patients Enrolled for Prostate Cancer

National Institute of Mental Health (NIMH)NIH

2,936 Previous Clinical Trials

2,751,615 Total Patients Enrolled

Rahul Aggarwal, MDPrincipal InvestigatorUniversity of California, San Francisco

22 Previous Clinical Trials

1,385 Total Patients Enrolled

13 Trials studying Prostate Cancer

1,043 Patients Enrolled for Prostate Cancer

Michael Evans, PhD4.4143 ReviewsPrincipal Investigator - University of California, San Francisco

MetroSouth Medical Center, Palos Community Hospital, Silver Cross Hospital

Medical School - University of Wisconsin, Doctor of Medicine

Medical College of Wisconsin, Residency in Orthopedic Surgery

1Patient Review

I found the office to be unappealing, and he seemed to be rushing through patients. He prescribed me a medication for something I'm not even sure what it is. Overall, not a great experience.