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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-choline Injection | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Age at Primary Treatment | The median age at primary treatment for Arm 2 participants. | The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study) |
| Median PSA at Diagnosis of Arm 2 Participants |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas H Tarter, M.D, Ph.D | Decatur Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
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No enrolled participants were excluded from either arm of the study prior to assignment.
Recruitment dates: 10/14 - 6/16, dosage and imaging only at Decatur Memorial Hospital in Decatur, IL.
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| ID | Title | Description |
|---|---|---|
| FG000 | 11C-choline for Staging of Recurrent Prostate Cancer | The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of 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 will not be further analyzed beyond that need for clinical diagnosis. |
| FG001 | 11C-choline Comparison Study of CT and MR 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 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 11C-choline for Staging of Recurrent Prostate Cancer | The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of 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 will not be further analyzed beyond that need for clinical diagnosis. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome. | Posted | Count of Participants | Participants | 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. |
Participants were monitored throughout the imaging process during the administration of the imaging agents and immediately thereafter. They were contacted within 1 day after the scan for assessment.
Adverse Events were assessed per the standard Adverse Events definition. Patients were contacted by telephone 24 hours post-C11 Choline PET scan for any follow-up concerns and were also told to report any immediate or additional concerns.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 11C-choline for Staging of Recurrent Prostate Cancer | The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of 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 will not be further analyzed beyond that need for clinical diagnosis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas H. Tarter, M.D., Ph.D - Director, Urologic Oncology, Cancer Care Specialists of Illinois | Decatur Memorial Hospital, Decatur, IL | (217) 876-6600 | ttarter@ccsci.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2015 | Mar 31, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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| 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 |
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. |
| 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 | 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. | 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) | 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 | 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. | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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). | The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study) |
| Observation, no biopsy |
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| Biopsy infeasible, ADT & rad. therapy |
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| Protocol Violation |
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| BG001 | 11C-choline Comparison Study of CT and MR 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 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | 11C-choline for Staging of Recurrent Prostate Cancer | The key objective of this study is to provide expanded access to C11 Choline as an investigational drug in geographical service areas where it is not available. Patients entered into this arm of 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 will not be further analyzed beyond that need for clinical diagnosis. |
| OG001 | 11C-choline Comparison Study of CT and MR 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 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
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| Primary | 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. | Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome. | Posted | Number | % of correctly identified positives | Approximately 1 day post-scan for patient results |
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| Primary | 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. | Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome. | Posted | Number | % correctly identified negatives | Approximately 1 day post-scan for patient results |
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| Primary | 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. | Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome. | Posted | Number | Probability of disease (%) | Approximately 1 day post-scan for patient results |
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| Primary | 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. | Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome. | Posted | Number | Probability of being disease-free (%) | Approximately 1 day post-scan for patient results |
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| Primary | 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. | This population only includes those Arm 2 participants with positive PET imaging. | Posted | Count of Participants | Participants | Approximately 1 day post-scan for patient results |
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| Secondary | Median Age at Primary Treatment | The median age at primary treatment for Arm 2 participants. | Only Arm 2 participants' data was collected. | Posted | Median | Full Range | years | The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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. | Only Arm 2 participants' data was collected. *Note: 4 participants' PSA was not reported. | Posted | Median | Full Range | ng/ml | The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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 | Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported. | Posted | Count of Participants | Participants | The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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. | Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant. | Posted | Median | Full Range | units on a scale | The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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) | Only data collected from Arm 2 Participants. | Posted | Count of Participants | Participants | The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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 | Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients. | Posted | Count of Participants | Participants | The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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. | Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants. | Posted | Count of Participants | Participants | The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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. | Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants. | Posted | Count of Participants | Participants | The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study) |
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| Secondary | 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 | only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant. | Posted | Count of Participants | Participants | The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study) |
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|
| Secondary | 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. | only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants. | Posted | Median | Full Range | months | The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| Secondary | 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. | Only data collected from Arm 2 participants is reported. | Posted | Median | Full Range | years | The participants' age at study entry was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| Secondary | 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 | only data collected for Arm 2 participants. | Posted | Median | Full Range | ng/ml of blood | The participants' PSA was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| Secondary | 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. | Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants. | Posted | Median | Full Range | months | The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| Secondary | 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. | Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants. | Posted | Median | Full Range | ng/mL/month | The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| Secondary | ADT (Androgen Deprivation Therapy) in Participant at PET Imaging | An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT). | Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants. | Posted | Count of Participants | Participants | The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 11C-choline Comparison Study of CT and MR 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 11C-choline Injection: 1. Choline C11 Injection for PET/CT Imaging Protocol:
| 0 | 95 | 0 | 95 | 0 | 95 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Positive PET, Positive CT, Positive MRI |
|
| Brachytherapy |
|
| Brachytherapy + EBRT |
|
| Cystoprostratectomy |
|
| EBRT |
|
| EBRT + ADT |
|
| IMRT |
|
| RP |
|
| pT3b |
|
| Title | Measurements |
|---|---|
|
| EBRT |
|
| Lycopene |
|
| None |
|
| Salvage RP |
|
| Salvage RT |
|
| Salvage RT + ADT |
|