Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

NCT02260817 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ZM-CCH-40-PTL0114
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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. 1.Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
2. 2.The CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
3. 3.The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer.
4. 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. 5.Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.
6. 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.

Conditions

Metastatic Prostate Cancer

Keywords

Prostate Cancer; 11C Choline; PET Imaging

Outcome Measures

Primary Outcomes (6)

• Evidence of Metastatic Prostate Cancer

  The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study. True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy. True Negative: True negatives will consist of negative images. False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment. False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment.

  After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.

• Sensitivity of 11C Choline PET Imaging Scans

  The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity. Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative). This Outcome is only measured for Arm 2 of this study.

  Approximately 1 day post-scan for patient results

• Specificity of 11C Choline PET Imaging Scans

  The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity. Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive). This Outcome is only measured and reported for Arm 2.

  Approximately 1 day post-scan for patient results

• Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans

  The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value. Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive). This Outcome is only measured for Arm 2.

  Approximately 1 day post-scan for patient results

• Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans

  The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value. Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative). This Outcome is only measured for Arm 2.

  Approximately 1 day post-scan for patient results

• Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation

  Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.

  Approximately 1 day post-scan for patient results

Secondary Outcomes (15)

• Median Age at Primary Treatment

  The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)

• Median PSA at Diagnosis of Arm 2 Participants

  The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)

• Clinical T (cT) Stage of Arm 2 Participants

  The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)

• Median Primary Biopsy Gleason Score of Arm 2 Participants

  The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)

• Primary Treatment Modality of Arm 2 Participants

  The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)

Study Arms (2)

Expanded Access for 11C-Choline

EXPERIMENTAL

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.

Drug: 11C-choline Injection

11C-Choline Comparison of Modalities

EXPERIMENTAL

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

Drug: 11C-choline Injection

Interventions

11C-choline Injection 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

Also known as: CCH Injection, C11 Choline Injection

11C-Choline Comparison of Modalities; Expanded Access for 11C-Choline

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For biochemical relapse after primary treatment
• PSA \> 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later
• PSA increase \>2 ng/ml from nadir following radiation therapy
• PSA increase \>2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level
• Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy
• Kidney function with GFR \> 60 mL/sec/1.73m2 and Creatinine \< 1.7mg, collected within 90 days of planned scan
• if GFR is \> or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast
• if GFR is \< 60 mL/sec/1.73m2, PET/CT will be completed without contrast
• if Creatinine is \> than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.
• No known allergy to iodinated radiologic contrast media
• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

You may not qualify if:

• ECOG Performance Status \> 2.
• Concurrent malignancy, i.e. colon cancer.
• Treatment for another malignancy except superficial skin cancer within 5 years

Sponsors & Collaborators

• Global Isotopes, LLC d/b/a Zevacor Molecular: lead

Study Sites (1)

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Thomas H. Tarter, M.D., Ph.D - Director, Urologic Oncology, Cancer Care Specialists of Illinois
• Organization: Decatur Memorial Hospital, Decatur, IL

ttarter@ccsci.net

(217) 876-6600

Study Officials

• Thomas H Tarter, M.D, Ph.D

  Decatur Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: October 9, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2018
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)