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Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (CONDOR)

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ClinicalTrials.gov Identifier: NCT03739684
Recruitment Status : Completed
First Posted : November 14, 2018
Results First Posted : June 14, 2021
Last Update Posted : June 14, 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
Conditions Prostate Cancer
Prostate Adenocarcinoma
Prostate Cancer Recurrent
Prostate Cancer Metastatic
Interventions Drug: 18F-DCFPyL
Diagnostic Test: PET/CT Imaging
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Period Title: Overall Study
Started 208
Completed 195
Not Completed 13
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Baseline Participants 208
Hide Baseline Analysis Population Description
Safety population; all participants who received any amount of 18F-DCFPyL
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 208 participants
68
(43 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants
Female
0
   0.0%
Male
208
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants
Asian
3
   1.4%
Black or African American
15
   7.2%
White
188
  90.4%
Other, including not reported
2
   1.0%
1.Primary Outcome
Title Correct Localization Rate (CLR)
Hide Description The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
Time Frame Within 60 days following 18F-DCFPyL PET/CT imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 208
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Central Reader 1
85.6
(78.8 to 92.3)
Central Reader 2
87.0
(80.4 to 93.6)
Central Reader 3
84.8
(77.8 to 91.9)
2.Secondary Outcome
Title Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
Hide Description The change in the intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after 18F-DCFPyL PET/CT imaging.
Time Frame Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a Medical Management Questionnaire (MMQ) completed at pre- and post- 18F-DCFPyL PET/CT imaging.
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 205
Measure Type: Count of Participants
Unit of Measure: Participants
131
  63.9%
3.Secondary Outcome
Title The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Hide Description The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Time Frame Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set includes all participants who received any amount of 18F-DECPyL.
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 208
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure: Baseline (actual) Number Analyzed 207 participants
138.9  (18.61)
Systolic Blood Pressure: Post-dosing (actual) Number Analyzed 202 participants
136.7  (17.15)
Systolic Blood Pressure: Change from Baseline Number Analyzed 202 participants
-2.2  (13.24)
Diastolic Blood Pressure: Baseline (actual) Number Analyzed 207 participants
78.5  (10.18)
Diastolic Blood Pressure: Post-dosing (actual) Number Analyzed 202 participants
77.3  (9.57)
Diastolic Blood Pressure: Change from Baseline Number Analyzed 202 participants
-1.2  (8.20)
4.Secondary Outcome
Title The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Hide Description The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Time Frame Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after 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 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 208
Mean (Standard Deviation)
Unit of Measure: bpm
Heart Rate: Baseline (actual) Number Analyzed 207 participants
69.3  (12.75)
Heart Rate: Post-dosing (actual) Number Analyzed 202 participants
65.1  (12.09)
Heart Rate: Change from Baseline Number Analyzed 202 participants
-4.3  (7.93)
5.Secondary Outcome
Title Collection of Concomitant Medications (Safety Outcome Measure)
Hide Description

Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants.

Results are presented where the percentage of participants within an ATC level 4 category is >5.0.

Time Frame From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL 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 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 208
Measure Type: Count of Participants
Unit of Measure: Participants
HMG COA REDUCTASE INHIBITORS
103
  49.5%
PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN)
63
  30.3%
ACE INHIBITORS, PLAIN
36
  17.3%
VITAMIN D AND ANALOGUES
32
  15.4%
ANGIOTENSIN II ANTAGONISTS, PLAIN
31
  14.9%
BETA BLOCKING AGENTS, SELECTIVE
31
  14.9%
DIHYDROPYRIDINE DERIVATIVES
31
  14.9%
PROTEIN PUMP INHIBITORS
29
  13.9%
DRUGS USED IN ERECTILE DYSFUNCTION
23
  11.1%
MULTIVITAMINS, PLAIN
18
   8.7%
BIGUANIDES
17
   8.2%
THIAZIDES, PLAIN
16
   7.7%
OTHER ANTIDEPRESSANTS
15
   7.2%
ALPHA-ADRENORECEPTOR ANTAGONISTS
12
   5.8%
PROPIONIC ACID DERIVATIVES
12
   5.8%
THYROID HORMONES
11
   5.3%
UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE
11
   5.3%
6.Secondary Outcome
Title Collection of Medical Procedures (Safety Outcome Measure)
Hide Description Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Time Frame From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL 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 18F-DCFPyL Injection
Hide Arm/Group Description:
Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Overall Number of Participants Analyzed 208
Measure Type: Count of Participants
Unit of Measure: Participants
Biopsy testes
1
   0.5%
Computerized tomogram
1
   0.5%
Nuclear magnetic resonance imaging
1
   0.5%
Ultrasound testes
1
   0.5%
Open reduction of fracture
1
   0.5%
Orchidectomy
1
   0.5%
Time Frame Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-DCFPyL Injection
Hide Arm/Group Description Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
All-Cause Mortality
18F-DCFPyL Injection
Affected / at Risk (%)
Total   0/208 (0.00%) 
Hide Serious Adverse Events
18F-DCFPyL Injection
Affected / at Risk (%)
Total   1/208 (0.48%) 
Immune system disorders   
Hypersensitivity * 1  1/208 (0.48%) 
Nervous system disorders   
Headache * 1  1/208 (0.48%) 
Paresthesia * 1  1/208 (0.48%) 
1
Term from vocabulary, MedDRA 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
18F-DCFPyL Injection
Affected / at Risk (%)
Total   7/208 (3.37%) 
General disorders   
Fatigue * 1  2/208 (0.96%) 
Nervous system disorders   
Headache * 1  3/208 (1.44%) 
Vascular disorders   
Hypertension * 1  2/208 (0.96%) 
1
Term from vocabulary, MedDRA 21.1
*
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: NCT03739684    
Other Study ID Numbers: PyL 3301
First Submitted: November 9, 2018
First Posted: November 14, 2018
Results First Submitted: May 16, 2021
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021