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

Primary Purpose

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Magnetic Resonance Imaging

Positron Emission Tomography

11C-YJH08

About this trial

This is an interventional diagnostic trial for Castration-Resistant Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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, 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

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)

Sites / Locations

University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A: 11C-YJH08 with PET/MRI or PET/CT

Cohort B: 11C-YJH08 with additional PET/MRI, PET/CT at progression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis.

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)

Will be descriptively reported along with range on a per-patient basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at patient level.

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)

Will be descriptively reported along with range on a per-lesion basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at lesion level.

Secondary Outcome Measures

Incidence of adverse events

As recorded by Common Terminology Criteria for Adverse Events Version 5.0 criteria and organ dosimetry of 11C-YJH08 PET. Will be descriptively reported.

Descriptive patterns of intra-tumoral uptake of 11C-YJH08 on whole body PET

Including by site of disease, uptake by tumor type, inter-tumoral and interpatient heterogeneity, and tumor-to-background signal.

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

Will be compared between dichotomized groups using the chi-squared test.

Association between baseline uptake on 11C-YJH08 PET with progression-free survival (Cohort B only)

The log rank test will be used to compare progression-free survival between dichotomized subgroups.

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

Will be compared between dichotomized groups using the chi-squared test.

Full Information

NCT ID

NCT04927663

First Posted

June 9, 2021

Last Updated

December 19, 2022

Sponsor

Michael Evans

Collaborators

U.S. Army Medical Research Acquisition Activity, National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT04927663

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 10, 2021 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Evans

Collaborators

U.S. Army Medical Research Acquisition Activity, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: 11C-YJH08 with PET/MRI or PET/CT

Arm Type

Experimental

Arm Description

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.

Arm Title

Cohort B: 11C-YJH08 with additional PET/MRI, PET/CT at progression

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan

Intervention Description

Undergo CT imaging

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Intervention Description

Undergo MRI

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Intervention Description

Undergo PET imaging

Intervention Type

Drug

Intervention Name(s)

11C-YJH08

Other Intervention Name(s)

Radioactive Tag, Radioactive Tracer, Radioactive Label

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

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

Description

Will be descriptively reported on a lesion-per-lesion basis, using as reference standard staging scans including computed tomography or magnetic resonance imaging of the chest/abdomen/pelvis.

Time Frame

Up to day 1 follow-up

Title

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)

Description

Will be descriptively reported along with range on a per-patient basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at patient level.

Time Frame

Up to 24 months

Title

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)

Description

Will be descriptively reported along with range on a per-lesion basis. Wilcoxon signed rank test will be used to compare the follow up to baseline PET scan values at lesion level.

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

As recorded by Common Terminology Criteria for Adverse Events Version 5.0 criteria and organ dosimetry of 11C-YJH08 PET. Will be descriptively reported.

Time Frame

Up to day 1 follow-up

Title

Descriptive patterns of intra-tumoral uptake of 11C-YJH08 on whole body PET

Description

Including by site of disease, uptake by tumor type, inter-tumoral and interpatient heterogeneity, and tumor-to-background signal.

Time Frame

Up to 24 months

Title

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

Description

Will be compared between dichotomized groups using the chi-squared test.

Time Frame

Up to 24 months

Title

Association between baseline uptake on 11C-YJH08 PET with progression-free survival (Cohort B only)

Description

The log rank test will be used to compare progression-free survival between dichotomized subgroups.

Time Frame

Up to 24 months

Title

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

Description

Will be compared between dichotomized groups using the chi-squared test.

Time Frame

Up to 24 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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, 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khadija Siddiqua

Phone

(310) 794-7329

khadija.siddiqua@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Evans, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khadija Siddiqua

Phone

310-794-7329

khadija.siddiqua@ucsf.edu

Phone

877-827-3222

cancertrials@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Michael Evans, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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