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This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).
Cohort B is complete and no longer recruiting subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL Injection | Experimental | 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL Injection | Drug | A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Measure | Description | Time Frame |
|---|---|---|
| Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). |
Not provided
Inclusion Criteria:
Cohort A Only:
Cohort B Only: [Enrollment is complete; No longer recruiting subjects]
Exclusion Criteria:
Cohort A Only:
Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Morris, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Kenneth J Pienta, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco (UCSF) - Mt. Zion Hospital | San Francisco | California | 94143 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | High Risk Prostate Cancer (Cohort A) | Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
| FG001 | Recurrent or Metastatic Prostate Cancer (Cohort B) | Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population; total number of patients who received 18F-DCFPyL injection.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Risk Prostate Cancer (Cohort A) | Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.
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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 | High Risk Prostate Cancer (Cohort A) | Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coronary artery disease | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysgeusia | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Myl | Lantheus Medical Imaging / Progenics Pharmaceuticals | 914-582-1120 | david.myl@lantheus.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2017 | May 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2018 | May 16, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
Not provided
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| PET/CT imaging | Diagnostic Test | PET/CT imaging will be acquired 1-2 hours post-PyL injection |
|
| Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). |
| Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | Changes in ECG pre-drug dosing and within 1-2 hours post-dosing |
| Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
| Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
| Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
| Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
| Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition). | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred. |
| Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results. | Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
| Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image. | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur. |
| Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. |
| Yale University Department of Radiology and Biomedical Imaging |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Washington University Mallinckrodt Institute of Radilogy | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Jewish General Hospital | Montreal | Quebec | Canada |
| Centre Hospitalier Universitaire de Quebec (CHUQ) | Québec | Canada |
| Recurrent or Metastatic Prostate Cancer (Cohort B) |
Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | High Risk Prostate Cancer (Cohort A) | High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. |
|
|
| Primary | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A) | The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
|
|
| Secondary | Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) | Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. | The Safety Set includes all participants who received any amount of 18F-DCFPyL. | Posted | Count of Participants | Participants | No | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). |
|
|
|
| Secondary | Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) | Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B. | The Safety Set includes all participants who received any amount of 18F-DCFPyL. | Posted | Count of Participants | Participants | No | From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). |
|
|
|
| Secondary | Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) | The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements). | Posted | Count of Participants | Participants | Changes in ECG pre-drug dosing and within 1-2 hours post-dosing |
|
|
|
| Secondary | Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) | The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements). | Posted | Mean | Standard Deviation | mm Hg | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
|
|
|
| Secondary | Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements). | Posted | Mean | Standard Deviation | beats per minute | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
|
|
|
| Secondary | Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) | The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements). | Posted | Mean | Standard Deviation | breaths per minute | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
|
|
|
| Secondary | Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) | The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements). | Posted | Mean | Standard Deviation | degrees Celsius | Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. |
|
|
|
| Secondary | Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition). | Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred. |
|
|
|
| Secondary | Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging | The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results. | The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result. | Posted | Count of Participants | Participants | Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken |
|
|
|
|
| Secondary | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
|
|
| Secondary | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A) | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
|
|
| Secondary | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
|
|
| Secondary | Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A) | Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image. | The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. |
|
|
|
| Secondary | Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B) | Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image. | The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur. |
|
|
|
| Secondary | Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants | Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study. | Posted | Mean | Standard Deviation | µCi/mL | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. |
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants | Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study. | Posted | Mean | Standard Deviation | h*μCi/ml | Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. |
|
|
|
| 0 |
| 268 |
| 1 |
| 268 |
| 26 |
| 268 |
| EG001 | Recurrent or Metastatic Prostate Cancer (Cohort B) | Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. | 0 | 117 | 6 | 117 | 1 | 117 |
| atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| Lower gastrointestinal haemmorhage | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| pyelonephritis, acute | Infections and infestations | MedDRA 19.1 | Non-systematic Assessment |
|
| hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| spinal cord compression | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| fatigue | General disorders | MedDRA 19.1 | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA 19.1 | Non-systematic Assessment |
|
Study results cannot be published before the earlier of a multi-site publication; or 18 months after the end of the Study at all sites; or confirmation by Sponsor that there will be no multi-site publication. The proposed publication must be submitted to Sponsor at least 60 days prior to publication so that Sponsor can delete Sponsor Confidential Information (other than Study results) and obtain a further 60 days to file on any invention disclosed in the proposed publication.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
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| Hemoglobin |
|
|
| Platelets |
|
|
| Erythrocytes |
|
|
| Leukocytes |
|
|
|
| Alanine Aminotransferase |
|
|
| Aspartate Aminotransferase |
|
|
| Bilirubin |
|
|
| Calcium |
|
|
| Creatinine |
|
|
| Glucose |
|
|
| Potassium |
|
|
| Urea Nitrogen |
|
|
| Abnormal ECG Evaluation |
|
| Systolic Blood Pressure: Post-dosing (Actual) |
|
|
| Systolic Blood Pressure: Change from Baseline |
|
|
| Diastolic Blood Pressure: Baseline (Actual) |
|
|
| Diastolic Blood Pressure: Post-dosing (Actual) |
|
|
| Diastolic Blood Pressure: Change from Baseline |
|
|
| Heart Rate: Post-dosing (Actual) |
|
|
| Heart Rate: Change from Baseline |
|
|
| Respiration Rate: Post-dosing (Actual) |
|
|
| Respiration Rate: Change from Baseline |
|
|
| Temperature: Post-dosing (Actual) |
|
|
| Temperature: Change from Baseline |
|
|
|
| Central Reader 3 |
|
|
|
| Tissue Site: Visceral/Soft Tissue |
|
|
| Tissue Site: Lymph Nodes |
|
|
| Tissue Site: Prostate Gland |
|
|
| Tissue Site: All |
|
|
| 0.1087 |
| Superiority |
| Tissue Site: Bone | Fisher Exact | 0.1949 | Superiority |
| Tissue Site: Bone | Fisher Exact | 0.1315 | Superiority |
| Tissue Site: Bone | Fisher Exact | 0.1977 | Superiority |
| Tissue Site: Bone | Fisher Exact | 0.2149 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.2582 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.0009 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.3588 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.8791 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.9457 | Superiority |
| Tissue Site: Visceral/Soft tissue | Fisher Exact | 0.2705 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | <0.0001 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | <0.0001 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | <0.0001 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | 0.5933 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | 0.7094 | Superiority |
| Tissue Type: Lymph nodes | Chi-squared | 0.5424 | Superiority |
| Tissue Site: Prostate Gland | Chi-squared | <0.0001 | Superiority |
| Tissue Site: Prostate Gland | Fisher Exact | <0.0001 | Superiority |
| Tissue Site: Prostate Gland | Fisher Exact | <0.0001 | Superiority |
| Tissue Site: Prostate Gland | Fisher Exact | 0.0038 | Superiority |
| Tissue Site: Prostate Gland | Fisher Exact | 0.0647 | Superiority |
| Tissue Site: Prostate Gland | Chi-squared | 0.0021 | Superiority |
| Tissue Site: All | Chi-squared | <0.0001 | Superiority |
| Tissue Site: All | Chi-squared | <0.0001 | Superiority |
| Tissue Site: All | Chi-squared | <0.0001 | Superiority |
| Tissue Site: All | Chi-squared | 0.0815 | Superiority |
| Tissue Site: All | Chi-squared | 0.7507 | Superiority |
| Tissue Site: All | Chi-squared | 0.5620 | Superiority |
| Title | Measurements |
|---|---|
|
| Central Reader 3 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Central Reader 3 |
|
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Low |
|
| Cohort A - Baseline Value: Normal |
|
| Cohort B - Baseline Value: Normal |
|
| Cohort A - Baseline Value: High |
|
| Cohort B - Baseline Value: High |
|
| Cohort A - Baseline Value: Missing |
|
| Cohort B - Baseline Value: Missing |
|
| Number of Lesions: 1-2 |
|
| Number of Lesions: 3-4 |
|
| Number of Lesions: 5-6 |
|
| Number of Lesions: >6 |
|
| Number of Lesions: 1-2 |
|
| Number of Lesions: 3-4 |
|
| Number of Lesions: 5-6 |
|
| Number of Lesions: >6 |
|
| Number of Lesions: 1-2 |
|
| Number of Lesions: 3-4 |
|
| Number of Lesions: 5-6 |
|
| Number of Lesions: >6 |
|
| Number of Lesions: 1-2 |
|
| Number of Lesions: 3-4 |
|
| Number of Lesions: 5-6 |
|
| Number of Lesions: >6 |
|