Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

NCT ID: NCT02260817

Last Updated: 2019-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-06-30

Brief Summary

This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment.

The purpose of this study is to:

A. Provide expanded access the drug 11C-choline.

B. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner.

C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.

D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively.

E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI

Study Protocol:

1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.

2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.

3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer.

4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging.

5. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.

6. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Detailed Description

1. The first arm of this study serves to provide expanded access to 11C-choline injection as currently defined under the reference listed drug label as an investigational drug in geographical service areas where 11C-choline is not available. The second arm expands access as well but also attempts to determine the more effective imaging modality and conditions between PET/CT and PET/MR.

2. The study will consist of patients who have a biochemical relapse or other evidence of relapse after primary treatment. The first arm of the study is open to as many patients who elect to participate in the study that are over the age of 18 and have experienced a biochemical relapse of prostate cancer after primary treatment. The second arm will consist of patients who have been treated with radiation therapy, or androgen suppression and radiation therapy who have a PSA > 2 ng/mL higher than the nadir level. The nadir level in patients who have been treated with androgen suppression and radiation therapy is determined after the serum testosterone level has normalized. This study group will also consist of patients who have been treated with radical prostatectomy and who have a biochemical relapse defined as a PSA of 0.2 ng/mL confirmed at that level or higher on a subsequent PSA test 3 months later. This group may consist of men who have other clinical evidence of relapse such as a suspicious bone scan or CT scan regardless of PSA kinetics. Patients identified as potential subjects will be screened against the eligibility criteria as defined above in Section 5.1.

3. Informed consent will be obtained from all participants before any study related procedures are conducted. Each participant will be informed about the nature of the study, its purpose, and possible risks. Informed consent will be documented by using the written informed consent document approved by the local IRB at the Decatur Memorial Hospital.

4. At the time of referral, patients will be asked to bring their prior records as it pertains to their prostate cancer history. Data collected from outside records, such as radiographic studies, previous imaging studies and biopsies will be incorporated into the study record.

5. Abstracted data for the study record will include:

1. Patient demographics such as age, race, and family history of prostate cancer

2. Risk factors such as finasteride or dutasteride use, and environmental exposure (eg. Agent orange)

3. Prostate exam results, most recent within last 90 days

4. PSA test results, most current and past

5. Past medical and surgical history

6. Current medications

7. Allergies

8. Pathology reports

9. Imaging reports

10. Date of diagnosis

11. Date(s) of biochemical relapse and coordinating PSA results. Once all records have been assessed for eligibility, an order for the 11C-choline PET CT scan and MRI scan will be requested from the referring physician and patient will be scheduled and given the appropriate prep instructions.

6. Both arms of the study will undergo a 11C-choline PET CT scan and MRI scan. The CT scan will be performed with intravenous contrast unless deemed unsafe by lab values. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Unequivocal evidence of metastasis on both conventional imaging and 11C-choline PET will be considered a true positive. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging. If confirmation of metastasis is not achievable by biopsy or surgical pathology, then confirmation will be achieved with 11C-choline PET CT and MRI images obtained 3 months after treatment conclusion. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.

7. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Conditions

Metastatic Prostate Cancer

Keywords

Prostate Cancer; 11C Choline; PET Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Expanded Access for 11C-Choline

The key objective of this study is to provide expanded access to this drug product as currently defined under the reference listed drug as an investigational drug in geographical service areas where 11C-choline injection is not available.

Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. Patient data obtained in this arm of the study will not be further analyzed beyond that need for clinical diagnosis.

Group Type: EXPERIMENTAL

11C-choline Injection

Intervention Type: DRUG

1. Choline C11 Injection for PET/CT Imaging Protocol:

• 15 - millicuries (mCi) 11C-choline IV Injection
• PET images skull base to mid thigh with 3 min per bed position
• Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
• Fusion of PET and CT images

2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:

• No IV contrast
• High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
• Fusion of coronal and PET images

11C-Choline Comparison of Modalities

11C-choline injection is approved for use in conjunction with both CT and MR imaging modalities. This arm will attempt to determine which modality is most efficacious and under which conditions.

Patients entered into the study will undergo imaging using GE's Trimodality Imaging System that combines PET, CT, and MR techniques to provide PET/CT and PET/MR fused images

Group Type: EXPERIMENTAL

11C-choline Injection

Intervention Type: DRUG

1. Choline C11 Injection for PET/CT Imaging Protocol:

• 15 - millicuries (mCi) 11C-choline IV Injection
• PET images skull base to mid thigh with 3 min per bed position
• Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
• Fusion of PET and CT images

2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:

• No IV contrast
• High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
• Fusion of coronal and PET images

Interventions

11C-choline Injection

1. Choline C11 Injection for PET/CT Imaging Protocol:

• 15 - millicuries (mCi) 11C-choline IV Injection
• PET images skull base to mid thigh with 3 min per bed position
• Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
• Fusion of PET and CT images

2. Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:

• No IV contrast
• High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
• Fusion of coronal and PET images

Intervention Type: DRUG

Other Intervention Names

CCH Injection, C11 Choline Injection

Eligibility Criteria

Inclusion Criteria

1. For biochemical relapse after primary treatment

1. PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later

2. PSA increase >2 ng/ml from nadir following radiation therapy

3. PSA increase >2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level

4. Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy

2. Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within 90 days of planned scan

1. if GFR is > or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast

2. if GFR is < 60 mL/sec/1.73m2, PET/CT will be completed without contrast

3. if Creatinine is > than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.

3. No known allergy to iodinated radiologic contrast media

4. Able to have MRI based on screening evaluation. If patient is found to be MRI incompatible, the 11C-choline PET/MRI portion of the study will not be completed. Please see the provided contact numbers for further options.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Exclusion Criteria

1. ECOG Performance Status > 2.

2. Concurrent malignancy, i.e. colon cancer.

3. Treatment for another malignancy except superficial skin cancer within 5 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Global Isotopes, LLC d/b/a Zevacor Molecular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas H Tarter, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Decatur Memorial Hospital

Locations

Decatur Memorial Hospital

Decatur, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZM-CCH-40-PTL0114

Identifier Type: -

Identifier Source: org_study_id