Metastatic Prostate CancerPhase 3NCT02260817
Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer
A Phase 3 study testing 11C-choline Injection in people with Metastatic Prostate Cancer, run by Global Isotopes, LLC d/b/a Zevacor Molecular at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- 11C-choline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- ECOG Performance Status > 2.
- Concurrent malignancy, i.e. colon cancer.
- Treatment for another malignancy except superficial skin cancer within 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
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:
Read more
- Provide expanded access the drug 11C-choline.
- 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.
- Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.
- 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.
- 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:
- Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
- 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.
- 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.
- Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.
- 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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- Abstracted data for the study record will include:
- Patient demographics such as age, race, and family history of prostate cancer
- Risk factors such as finasteride or dutasteride use, and environmental exposure (eg. Agent orange)
- Prostate exam results, most recent within last 90 days
- PSA test results, most current and past
- Past medical and surgical history
- Current medications
- Allergies
- Pathology reports
- Imaging reports
- Date of diagnosis
- 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.
- 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.
- 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
- Being tested
- 11C-choline Injection
- Keywords
- Prostate Cancer, 11C Choline, PET Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-choline InjectionDrug
Also called CCH Injection, C11 Choline Injection
- 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
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: 11C-choline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 1 day post-scan for patient results
Secondary outcomes (15)
Median Age at Primary Treatment
The median age at primary treatment for Arm 2 participants.
Measured: 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 Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.
Measured: The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)
Clinical T (cT) Stage of Arm 2 Participants
An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.
T1: PC is too small to be seen on a scan or felt during prostate examination
T1a: PC is in < 5% of removed tissue
T1b: PC is in > 5% or more of removed tissue
T1c: PC is found by biopsy
T2: PC is completely inside prostate
T2a: PC is in only half of one side of prostate
T2b: PC is in more than half of one side of prostate, but not both sides
T2c: PC is in both sides but is still inside prostate
T3: PC has broken through the capsule of prostate
T3a: PC has broken through the capsule of prostate
T3b: PC has spread into seminal vesicles
T4: PC has spread into other nearby body organs
Measured: 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 median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.
The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.
Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).
The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.
Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured.
Measured: The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)
Primary Treatment Modality of Arm 2 Participants
An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.
Modalities reported below are:
Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)
Measured: The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.
T1: PC is too small to be seen on a scan or felt during prostate examination
T1a: PC is in < 5% of removed tissue
T1b: PC is in > 5% or more of removed tissue
T1c: PC is found by biopsy
T2: PC is completely inside prostate
T2a: PC is in only half of one side of prostate
T2b: PC is in more than half of one side of prostate, but not both sides
T2c: PC is in both sides but is still inside prostate
T3: PC has broken through the capsule of prostate
T3a: PC has broken through the capsule of prostate
T3b: PC has spread into seminal vesicles
T4: PC has spread into other nearby body organs
Measured: The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)
Primary Surgical Margins of Arm 2 Participants
A census of the primary surgical margins of participants in Arm 2 will reported.
The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.
Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present.
Measured: The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)
Primary Positive Lymph Node Ratio of Arm 2 Participants
A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.
The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer.
Measured: The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)
Additional Treatment and Type for Arm 2 Participants
A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.
None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection
Measured: The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)
Median Months to Biochemical Relapse of Arm 2 Participants
The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.
Measured: The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)
Median Age of Arm 2 Participant at PET Imaging
The median age (at time of study) of participants of Arm 2 will be reported in years.
Measured: The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)
Median PSA of Arm 2 Participant at PET Imaging
The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood
Measured: The participants' PSA was collected upon study enrollment (approximately 1 week into study)
Median PSA Doubling Time of Arm 2 Participants at PET Imaging
The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.
Measured: The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)
Median PSA Velocity of Arm 2 Participants at PET Imaging
The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.
Measured: The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)
ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).
Measured: The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Isotopes, LLC d/b/a Zevacor Molecular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas H Tarter, M.D, Ph.D, Principal investigator, Decatur Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260817
- Sponsor's protocol ID
- ZM-CCH-40-PTL0114
- Status last verified
- Dec 2019
- First submitted
- 4 Aug 2014
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to 11C Choline PET/CT and 11C Choline PET/MR for Staging of Recurrent Prostate Cancer With Comparison Study of CT and MR Modalities
- ClinicalTrials.gov ID
- NCT02260817
- Acronym / sponsor ID
- ZM-CCH-40-PTL0114
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate Cancer, 11C Choline, PET Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Global Isotopes, LLC d/b/a Zevacor MolecularIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Provide expanded access the drug 11C-choline.
- 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.
- Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study.
- 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.
- 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:
- Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan.
- 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.
- 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.
- Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images.
- 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
- 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.
- 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.
- 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.
- 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.
- Abstracted data for the study record will include:
- Patient demographics such as age, race, and family history of prostate cancer
- Risk factors such as finasteride or dutasteride use, and environmental exposure (eg. Agent orange)
- Prostate exam results, most recent within last 90 days
- PSA test results, most current and past
- Past medical and surgical history
- Current medications
- Allergies
- Pathology reports
- Imaging reports
- Date of diagnosis
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expanded Access for 11C-Choline | Experimental | Drug: 11C-choline InjectionThe 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. |
| 11C-Choline Comparison of Modalities | Experimental | Drug: 11C-choline Injection11C-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For biochemical relapse after primary treatment
- Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine < 1.7mg, collected within 90 days of planned scan
- 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
Key exclusion criteria (3 listed)
- ECOG Performance Status > 2.
- Concurrent malignancy, i.e. colon cancer.
- Treatment for another malignancy except superficial skin cancer within 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 11C-choline InjectionAlso: CCH Injection, C11 Choline Injection1. 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 | Drug | 11C-Choline Comparison of Modalities, Expanded Access for 11C-Choline |
Primary outcome
Evidence of Metastatic Prostate Cancer
Time frame: 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.
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.
Sensitivity of 11C Choline PET Imaging Scans
Time frame: Approximately 1 day post-scan for patient results
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.
Specificity of 11C Choline PET Imaging Scans
Time frame: Approximately 1 day post-scan for patient results
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.
Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans
Time frame: Approximately 1 day post-scan for patient results
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.
Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans
Time frame: Approximately 1 day post-scan for patient results
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.
Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation
Time frame: Approximately 1 day post-scan for patient results
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.
15 secondary outcomes
Median Age at Primary Treatment
Time frame: The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)
Median PSA at Diagnosis of Arm 2 Participants
Time frame: The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)
Clinical T (cT) Stage of Arm 2 Participants
Time frame: The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)
Median Primary Biopsy Gleason Score of Arm 2 Participants
Time frame: The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)
Primary Treatment Modality of Arm 2 Participants
Time frame: The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)
Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants
Time frame: The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)
Primary Surgical Margins of Arm 2 Participants
Time frame: The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)
Primary Positive Lymph Node Ratio of Arm 2 Participants
Time frame: The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)
Additional Treatment and Type for Arm 2 Participants
Time frame: The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)
Median Months to Biochemical Relapse of Arm 2 Participants
Time frame: The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)
Median Age of Arm 2 Participant at PET Imaging
Time frame: The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)
Median PSA of Arm 2 Participant at PET Imaging
Time frame: The participants' PSA was collected upon study enrollment (approximately 1 week into study)
Median PSA Doubling Time of Arm 2 Participants at PET Imaging
Time frame: The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)
Median PSA Velocity of Arm 2 Participants at PET Imaging
Time frame: The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)
ADT (Androgen Deprivation Therapy) in Participant at PET Imaging
Time frame: The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Tarter, M.D, Ph.D principal investigator
Decatur Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 11C-choline Injection in people with Metastatic Prostate Cancer, run by Global Isotopes, LLC d/b/a Zevacor Molecular at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Metastatic Prostate Cancer (time frame: 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.