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Trial record 1 of 1 for:    NCT02981368
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Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (OSPREY)

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ClinicalTrials.gov Identifier: NCT02981368
Recruitment Status : Completed
First Posted : December 5, 2016
Results First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Interventions Drug: 18F-DCFPyL Injection
Diagnostic Test: PET/CT imaging
Enrollment 385
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 268 117
Completed 248 102
Not Completed 20 15
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B) Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 268 117 385
Hide Baseline Analysis Population Description
Safety population; total number of patients who received 18F-DCFPyL injection.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 268 participants 117 participants 385 participants
65
(46 to 84)
68
(45 to 86)
66
(45 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 117 participants 385 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
268
 100.0%
117
 100.0%
385
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 268 participants 117 participants 385 participants
White
233
  86.9%
101
  86.3%
334
  86.8%
Black or African American
23
   8.6%
6
   5.1%
29
   7.5%
Asian
7
   2.6%
4
   3.4%
11
   2.9%
Other
2
   0.7%
3
   2.6%
5
   1.3%
Unknown or Not Reported
3
   1.1%
3
   2.6%
6
   1.6%
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
97.9
(94.52 to 99.37)
Central Reader 2
98.9
(96.00 to 99.96)
Central Reader 3
96.3
(93.64 to 98.99)
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
41.9
(29.65 to 54.22)
Central Reader 2
30.6
(19.17 to 42.12)
Central Reader 3
40.3
(28.11 to 52.53)
3.Secondary Outcome
Title Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Hide Description 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.
Time Frame From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL.
Arm/Group Title Cohort A - Follow-up Value: Low Cohort B - Follow-up Value: Low Cohort A - Follow-up Value: Normal Cohort B - Follow-up Value Normal Cohort A - Follow-up Value: High Cohort B - Follow-up Value: High Cohort A - Follow-up Value: Missing Cohort B - Follow-up Value: Missing
Hide Arm/Group Description:
Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.
Overall Number of Participants Analyzed 268 117 268 117 268 117 268 117
Measure Type: Count of Participants
Unit of Measure: Participants
Hematocrit Number Analyzed 55 participants 32 participants 197 participants 53 participants 2 participants 0 participants 14 participants 32 participants
Cohort A - Baseline Value: Low 26 0 12 0 0 0 2 0
Cohort B - Baseline Value: Low 0 31 0 6 0 0 0 10
Cohort A - Baseline Value: Normal 29 0 179 0 1 0 12 0
Cohort B - Baseline Value: Normal 0 1 0 47 0 0 0 22
Cohort A - Baseline Value: High 0 0 4 0 1 0 0 0
Cohort B - Baseline Value: High 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Hemoglobin Number Analyzed 34 participants 35 participants 218 participants 50 participants 2 participants 0 participants 14 participants 32 participants
Cohort A - Baseline Value: Low 16 0 3 0 0 0 2 0
Cohort B - Baseline Value: Low 0 33 0 6 0 0 0 13
Cohort A - Baseline Value: Normal 18 0 210 0 1 0 11 0
Cohort B - Baseline Value: Normal 0 2 0 43 0 0 0 18
Cohort A - Baseline Value: High 0 0 3 0 1 0 1 0
Cohort B - Baseline Value: High 0 0 0 1 0 0 0 1
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Platelets Number Analyzed 16 participants 12 participants 237 participants 72 participants 1 participants 1 participants 14 participants 32 participants
Cohort A - Baseline Value: Low 12 0 3 0 0 0 1 0
Cohort B - Baseline Value: Low 0 9 0 2 0 0 0 3
Cohort A - Baseline Value: Normal 4 0 230 0 1 0 13 0
Cohort B - Baseline Value: Normal 0 3 0 70 0 0 0 29
Cohort A - Baseline Value: High 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: High 0 0 0 0 0 1 0 0
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Erythrocytes Number Analyzed 49 participants 42 participants 205 participants 42 participants 0 participants 1 participants 14 participants 32 participants
Cohort A - Baseline Value: Low 29 0 8 0 0 0 2 0
Cohort B - Baseline Value: Low 0 36 0 1 0 0 0 10
Cohort A - Baseline Value: Normal 20 0 194 0 0 0 11 0
Cohort B - Baseline Value: Normal 0 6 0 39 0 0 0 22
Cohort A - Baseline Value: High 0 0 1 0 0 0 1 0
Cohort B - Baseline Value: High 0 0 0 2 0 1 0 0
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Leukocytes Number Analyzed 11 participants 7 participants 220 participants 75 participants 23 participants 3 participants 14 participants 32 participants
Cohort A - Baseline Value: Low 7 0 3 0 0 0 2 0
Cohort B - Baseline Value: Low 0 7 0 1 0 0 0 2
Cohort A - Baseline Value: Normal 4 0 208 0 18 0 12 0
Cohort B - Baseline Value: Normal 0 0 0 71 0 1 0 30
Cohort A - Baseline Value: High 0 0 7 0 5 0 0 0
Cohort B - Baseline Value: High 0 0 0 3 0 2 0 0
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
4.Secondary Outcome
Title Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
Hide Description 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.
Time Frame From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL.
Arm/Group Title Cohort A - Follow-up Value: Low Cohort B - Follow-up Value: Low Cohort A - Follow-up Value: Normal Cohort B - Follow-up Value: Normal Cohort A - Follow-up Value: High Cohort B - Follow-up Value: High Cohort A - Follow-up Value: Missing Cohort B - Follow-up Value: Missing
Hide Arm/Group Description:
Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.
Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned conventional image-guided biopsy.
Overall Number of Participants Analyzed 268 117 268 117 268 117 268 117
Measure Type: Count of Participants
Unit of Measure: Participants
Alkaline Phosphatase Number Analyzed 8 participants 0 participants 218 participants 61 participants 3 participants 13 participants 39 participants 43 participants
Cohort A - Baseline Value: Low 3 0 3 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 4
Cohort A - Baseline Value: Normal 5 0 210 0 0 0 38 0
Cohort B - Baseline Value: Normal 0 0 0 61 0 4 0 35
Cohort A - Baseline Value: High 0 0 4 0 3 0 0 0
Cohort B - Baseline Value: High 0 0 0 0 0 9 0 4
Cohort A - Baseline Value: Missing 0 0 1 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Alanine Aminotransferase Number Analyzed 0 participants 1 participants 207 participants 67 participants 21 participants 6 participants 40 participants 43 participants
Cohort A - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Normal 0 0 197 0 7 0 35 0
Cohort B - Baseline Value: Normal 0 1 0 67 0 2 0 42
Cohort A - Baseline Value: High 0 0 9 0 14 0 4 0
Cohort B - Baseline Value: High 0 0 0 0 0 4 0 1
Cohort A - Baseline Value: Missing 0 0 1 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Aspartate Aminotransferase Number Analyzed 12 participants 0 participants 199 participants 61 participants 12 participants 10 participants 45 participants 46 participants
Cohort A - Baseline Value: Low 4 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Normal 8 0 193 0 4 0 43 0
Cohort B - Baseline Value: Normal 0 0 0 60 0 4 0 45
Cohort A - Baseline Value: High 0 0 4 0 8 0 1 0
Cohort B - Baseline Value: High 0 0 0 1 0 5 0 1
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 1 0 0
Bilirubin Number Analyzed 1 participants 0 participants 200 participants 70 participants 28 participants 4 participants 39 participants 43 participants
Cohort A - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Normal 1 0 194 0 22 0 33 0
Cohort B - Baseline Value: Normal 0 0 0 69 0 2 0 41
Cohort A - Baseline Value: High 0 0 5 0 6 0 5 0
Cohort B - Baseline Value: High 0 0 0 1 0 2 0 2
Cohort A - Baseline Value: Missing 0 0 1 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Calcium Number Analyzed 26 participants 1 participants 223 participants 83 participants 1 participants 0 participants 18 participants 33 participants
Cohort A - Baseline Value: Low 1 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 1 0 0 0 0
Cohort A - Baseline Value: Normal 25 0 219 0 0 0 18 0
Cohort B - Baseline Value: Normal 0 1 0 81 0 0 0 32
Cohort A - Baseline Value: High 0 0 2 0 1 0 0 0
Cohort B - Baseline Value: High 0 0 0 1 0 0 0 1
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 0 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
Creatinine Number Analyzed 2 participants 5 participants 231 participants 71 participants 19 participants 8 participants 16 participants 33 participants
Cohort A - Baseline Value: Low 1 0 3 0 0 0 0 0
Cohort B - Baseline Value: Low 0 3 0 1 0 0 0 0
Cohort A - Baseline Value: Normal 1 0 223 0 9 0 15 0
Cohort B - Baseline Value: Normal 0 2 0 66 0 2 0 32
Cohort A - Baseline Value: High 0 0 4 0 8 0 0 0
Cohort B - Baseline Value: High 0 0 0 3 0 6 0 1
Cohort A - Baseline Value: Missing 0 0 1 0 2 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 1 0 0 0 0
Glucose Number Analyzed 0 participants 2 participants 178 participants 39 participants 73 participants 43 participants 17 participants 33 participants
Cohort A - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Normal 0 0 155 0 19 0 9 0
Cohort B - Baseline Value: Normal 0 2 0 25 0 14 0 16
Cohort A - Baseline Value: High 0 0 20 0 53 0 7 0
Cohort B - Baseline Value: High 0 0 0 13 0 29 0 17
Cohort A - Baseline Value: Missing 0 0 3 0 1 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 1 0 0 0 0
Potassium Number Analyzed 5 participants 2 participants 237 participants 78 participants 7 participants 1 participants 19 participants 36 participants
Cohort A - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 1 0 0 0 0
Cohort A - Baseline Value: Normal 5 0 226 0 7 0 18 0
Cohort B - Baseline Value: Normal 0 2 0 75 0 0 0 35
Cohort A - Baseline Value: High 0 0 7 0 0 0 0 0
Cohort B - Baseline Value: High 0 0 0 1 0 1 0 1
Cohort A - Baseline Value: Missing 0 0 4 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 1 0 0 0 0
Urea Nitrogen Number Analyzed 3 participants 0 participants 235 participants 58 participants 15 participants 24 participants 15 participants 35 participants
Cohort A - Baseline Value: Low 2 0 0 0 0 0 0 0
Cohort B - Baseline Value: Low 0 0 0 0 0 0 0 0
Cohort A - Baseline Value: Normal 1 0 222 0 8 0 12 0
Cohort B - Baseline Value: Normal 0 0 0 54 0 8 0 25
Cohort A - Baseline Value: High 0 0 11 0 7 0 2 0
Cohort B - Baseline Value: High 0 0 0 4 0 16 0 10
Cohort A - Baseline Value: Missing 0 0 2 0 0 0 1 0
Cohort B - Baseline Value: Missing 0 0 0 0 0 0 0 0
5.Secondary Outcome
Title Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
Hide Description [Not Specified]
Time Frame Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title High Risk Prostate Cancer (Cohort A) - Baseline ECG High Risk Prostate Cancer (Cohort A) - Post-dosing ECG Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
Overall Number of Participants Analyzed 260 264 114 115
Measure Type: Count of Participants
Unit of Measure: Participants
Normal ECG Evaluation
159
  61.2%
155
  58.7%
55
  48.2%
51
  44.3%
Abnormal ECG Evaluation
101
  38.8%
109
  41.3%
59
  51.8%
64
  55.7%
6.Secondary Outcome
Title Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Hide Description [Not Specified]
Time Frame Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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.
Overall Number of Participants Analyzed 268 117
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic Blood Pressure: Baseline (Actual) Number Analyzed 268 participants 117 participants
133.7  (15.99) 133.6  (19.00)
Systolic Blood Pressure: Post-dosing (Actual) Number Analyzed 265 participants 114 participants
133.7  (16.57) 132.1  (19.11)
Systolic Blood Pressure: Change from Baseline Number Analyzed 265 participants 114 participants
0.1  (12.30) -1.3  (11.57)
Diastolic Blood Pressure: Baseline (Actual) Number Analyzed 268 participants 117 participants
79.3  (8.62) 77.2  (10.16)
Diastolic Blood Pressure: Post-dosing (Actual) Number Analyzed 265 participants 114 participants
78.5  (9.12) 76.4  (9.02)
Diastolic Blood Pressure: Change from Baseline Number Analyzed 265 participants 114 participants
-0.7  (7.04) -0.7  (8.18)
7.Secondary Outcome
Title Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Hide Description [Not Specified]
Time Frame Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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.
Overall Number of Participants Analyzed 268 117
Mean (Standard Deviation)
Unit of Measure: beats per minute
Heart Rate: Baseline (Actual) Number Analyzed 268 participants 117 participants
70.7  (12.03) 71.3  (12.94)
Heart Rate: Post-dosing (Actual) Number Analyzed 265 participants 114 participants
66.4  (10.98) 67.0  (11.23)
Heart Rate: Change from Baseline Number Analyzed 265 participants 114 participants
-4.4  (6.88) -4.6  (6.53)
8.Secondary Outcome
Title Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Hide Description [Not Specified]
Time Frame Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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.
Overall Number of Participants Analyzed 265 117
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Respiration Rate: Baseline (Actual) Number Analyzed 265 participants 117 participants
16.7  (3.33) 17.3  (2.16)
Respiration Rate: Post-dosing (Actual) Number Analyzed 260 participants 114 participants
16.6  (3.32) 17.3  (2.28)
Respiration Rate: Change from Baseline Number Analyzed 260 participants 114 participants
-0.1  (2.03) 0.0  (2.00)
9.Secondary Outcome
Title Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
Hide Description [Not Specified]
Time Frame Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) 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.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) 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.
Overall Number of Participants Analyzed 266 117
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Temperature: Baseline (Actual) Number Analyzed 266 participants 117 participants
36.58  (0.433) 36.56  (0.338)
Temperature: Post-dosing (Actual) Number Analyzed 263 participants 113 participants
36.50  (0.479) 36.59  (0.309)
Temperature: Change from Baseline Number Analyzed 261 participants 113 participants
-0.08  (0.496) 0.03  (0.265)
10.Secondary Outcome
Title 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)
Hide Description 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).
Time Frame Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
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Hide Analysis Population Description
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.
Arm/Group Title Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1 Number Analyzed 92 participants
98.6
(91.60 to 100.00)
Central Reader 2 Number Analyzed 93 participants
95.8
(87.81 to 99.04)
Central Reader 3 Number Analyzed 92 participants
92.9
(83.98 to 97.28)
11.Secondary Outcome
Title Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
Hide Description 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.
Time Frame Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
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Hide Analysis Population Description
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.
Arm/Group Title Cohort A - Conventional Imaging Cohort A - 18F-DCFPyL PET/CT: Reader 1 Cohort A - 18F-DCFPyL PET/CT: Reader 2 Cohort A - 18F-DCFPyL PET/CT: Reader 3 Cohort B - Conventional Imaging Cohort B - 18F-DCFPyL PET/CT: Reader 1 Cohort B - 18F-DCFPyL PET/CT: Reader 2 Cohort B - 18F-DCFPyL PET/CT: Reader 3
Hide Arm/Group Description:
High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.
Overall Number of Participants Analyzed 252 252 252 252 92 93 93 93
Measure Type: Count of Participants
Unit of Measure: Participants
Tissue Site: Bone Number Analyzed 251 participants 252 participants 252 participants 252 participants 92 participants 93 participants 93 participants 93 participants
Number of Lesions: 0
239
  95.2%
234
  92.9%
247
  98.0%
237
  94.0%
37
  40.2%
22
  23.7%
28
  30.1%
23
  24.7%
Number of Lesions: 1-2
9
   3.6%
17
   6.7%
4
   1.6%
13
   5.2%
20
  21.7%
21
  22.6%
24
  25.8%
22
  23.7%
Number of Lesions: 3-4
0
   0.0%
1
   0.4%
1
   0.4%
2
   0.8%
8
   8.7%
10
  10.8%
4
   4.3%
10
  10.8%
Number of Lesions: 5-6
2
   0.8%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
3
   3.2%
5
   5.4%
2
   2.2%
Number of Lesions: >6
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
26
  28.3%
37
  39.8%
32
  34.4%
36
  38.7%
Tissue Site: Visceral/Soft Tissue Number Analyzed 251 participants 252 participants 252 participants 252 participants 92 participants 93 participants 93 participants 93 participants
Number of Lesions: 0
233
  92.8%
241
  95.6%
249
  98.8%
240
  95.2%
72
  78.3%
71
  76.3%
73
  78.5%
64
  68.8%
Number of Lesions: 1-2
16
   6.4%
11
   4.4%
3
   1.2%
12
   4.8%
13
  14.1%
15
  16.1%
14
  15.1%
20
  21.5%
Number of Lesions: 3-4
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
3
   3.3%
2
   2.2%
1
   1.1%
4
   4.3%
Number of Lesions: 5-6
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.2%
1
   1.1%
2
   2.2%
0
   0.0%
Number of Lesions: >6
1
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.2%
4
   4.3%
3
   3.2%
5
   5.4%
Tissue Site: Lymph Nodes Number Analyzed 251 participants 252 participants 252 participants 252 participants 92 participants 93 participants 93 participants 93 participants
Number of Lesions: 0
157
  62.5%
216
  85.7%
226
  89.7%
218
  86.5%
37
  40.2%
38
  40.9%
37
  39.8%
38
  40.9%
Number of Lesions: 1-2
39
  15.5%
28
  11.1%
19
   7.5%
25
   9.9%
18
  19.6%
11
  11.8%
16
  17.2%
10
  10.8%
Number of Lesions: 3-4
10
   4.0%
5
   2.0%
4
   1.6%
5
   2.0%
8
   8.7%
7
   7.5%
13
  14.0%
10
  10.8%
Number of Lesions: 5-6
16
   6.4%
3
   1.2%
3
   1.2%
3
   1.2%
7
   7.6%
8
   8.6%
4
   4.3%
8
   8.6%
Number of Lesions: >6
29
  11.6%
0
   0.0%
0
   0.0%
1
   0.4%
22
  23.9%
29
  31.2%
23
  24.7%
27
  29.0%
Tissue Site: Prostate Gland Number Analyzed 250 participants 252 participants 252 participants 252 participants 91 participants 93 participants 93 participants 93 participants
Number of Lesions: 0
162
  64.8%
5
   2.0%
5
   2.0%
14
   5.6%
79
  86.8%
64
  68.8%
69
  74.2%
63
  67.7%
Number of Lesions: 1-2
88
  35.2%
199
  79.0%
209
  82.9%
204
  81.0%
12
  13.2%
20
  21.5%
22
  23.7%
30
  32.3%
Number of Lesions: 3-4
0
   0.0%
38
  15.1%
33
  13.1%
31
  12.3%
0
   0.0%
6
   6.5%
1
   1.1%
0
   0.0%
Number of Lesions: 5-6
0
   0.0%
10
   4.0%
4
   1.6%
3
   1.2%
0
   0.0%
1
   1.1%
0
   0.0%
0
   0.0%
Number of Lesions: >6
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
0
   0.0%
2
   2.2%
1
   1.1%
0
   0.0%
Tissue Site: All Number Analyzed 252 participants 252 participants 252 participants 252 participants 92 participants 93 participants 93 participants 93 participants
Number of Lesions: 0
109
  43.3%
3
   1.2%
5
   2.0%
14
   5.6%
14
  15.2%
3
   3.2%
11
  11.8%
7
   7.5%
Number of Lesions: 1-2
75
  29.8%
174
  69.0%
196
  77.8%
175
  69.4%
11
  12.0%
15
  16.1%
17
  18.3%
14
  15.1%
Number of Lesions: 3-4
16
   6.3%
55
  21.8%
38
  15.1%
47
  18.7%
8
   8.7%
10
  10.8%
9
   9.7%
8
   8.6%
Number of Lesions: 5-6
17
   6.7%
9
   3.6%
10
   4.0%
11
   4.4%
9
   9.8%
9
   9.7%
10
  10.8%
11
  11.8%
Number of Lesions: >6
35
  13.9%
11
   4.4%
3
   1.2%
5
   2.0%
50
  54.3%
56
  60.2%
46
  49.5%
53
  57.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1097
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1087
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1949
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1315
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1977
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Bone
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2149
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2582
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3588
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8791
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9457
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Visceral/Soft tissue
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2705
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5933
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7094
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Type: Lymph nodes
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5424
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0647
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: Prostate Gland
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Cohort A - Conventional Imaging, Cohort A - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 1
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0815
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 2
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7507
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Cohort B - Conventional Imaging, Cohort B - 18F-DCFPyL PET/CT: Reader 3
Comments Tissue Site: All
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5620
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
12.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 247
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
100.0
(98.1 to 100.0)
Central Reader 2
100.0
(98.1 to 100.0)
Central Reader 3
100.0
(98.1 to 100.0)
13.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 247
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
0 [1] 
(NA to NA)
Central Reader 2
0 [1] 
(NA to NA)
Central Reader 3
0 [1] 
(NA to NA)
[1]
NPV was 0 - no participant had negative histology in the prostate.
14.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
86.7
(69.7 to 95.3)
Central Reader 2
90.5
(69.9 to 98.6)
Central Reader 3
78.1
(63.8 to 92.5)
15.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High Risk Prostate Cancer (Cohort A)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 252
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
83.8
(78.9 to 88.6)
Central Reader 2
81.4
(76.4 to 86.4)
Central Reader 3
83.2
(78.2 to 88.1)
16.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
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Hide Analysis Population Description
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.
Arm/Group Title Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description:
Participants 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.
Overall Number of Participants Analyzed 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1 Number Analyzed 92 participants
81.2
(72.9 to 89.5)
Central Reader 2 Number Analyzed 93 participants
81.9
(73.7 to 90.2)
Central Reader 3 Number Analyzed 92 participants
87.8
(80.4 to 95.3)
17.Secondary Outcome
Title Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
Hide Description [Not Specified]
Time Frame Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)
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A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: µCi/mL
0.43  (0.088)
18.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
Hide Description [Not Specified]
Time Frame Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)
Hide Arm/Group Description:
A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: h*μCi/ml
0.82  (0.143)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/268 (0.00%)   0/117 (0.00%) 
Hide Serious Adverse Events
High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/268 (0.37%)   6/117 (5.13%) 
Cardiac disorders     
coronary artery disease * 1  1/268 (0.37%)  1/117 (0.85%) 
atrial fibrillation * 1  0/268 (0.00%)  1/117 (0.85%) 
Gastrointestinal disorders     
Lower gastrointestinal haemmorhage * 1  0/268 (0.00%)  1/117 (0.85%) 
Infections and infestations     
pyelonephritis, acute * 1  0/268 (0.00%)  1/117 (0.85%) 
Metabolism and nutrition disorders     
hyperkalaemia * 1  0/268 (0.00%)  1/117 (0.85%) 
Nervous system disorders     
spinal cord compression * 1  0/268 (0.00%)  1/117 (0.85%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
High Risk Prostate Cancer (Cohort A) Recurrent or Metastatic Prostate Cancer (Cohort B)
Affected / at Risk (%) Affected / at Risk (%)
Total   26/268 (9.70%)   1/117 (0.85%) 
Gastrointestinal disorders     
diarrhea * 1  3/268 (1.12%)  0/117 (0.00%) 
General disorders     
fatigue * 1  5/268 (1.87%)  0/117 (0.00%) 
Nervous system disorders     
dysgeusia * 1  9/268 (3.36%)  1/117 (0.85%) 
headache * 1  9/268 (3.36%)  0/117 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Myl
Organization: Lantheus Medical Imaging / Progenics Pharmaceuticals
Phone: 914-582-1120
EMail: david.myl@lantheus.com
Layout table for additonal information
Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02981368    
Other Study ID Numbers: PyL 2301
First Submitted: November 22, 2016
First Posted: December 5, 2016
Results First Submitted: May 16, 2021
Results First Posted: August 9, 2021
Last Update Posted: August 9, 2021