CONDOR: Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Study Details
Study Description
Brief Summary
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 18F-DCFPyL Injection 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
Drug: 18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
Other Names:
Diagnostic Test: PET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
|
Outcome Measures
Primary Outcome Measures
- Correct Localization Rate (CLR) [Within 60 days following 18F-DCFPyL PET/CT imaging.]
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.
Secondary Outcome Measures
- Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. [Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.]
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.
- The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) [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.]
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) [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.]
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- Collection of Concomitant Medications (Safety Outcome Measure) [From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.]
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.
- Collection of Medical Procedures (Safety Outcome Measure) [From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.]
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male >/= 18 years of age
-
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
-
Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
-
Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
-
Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
-
Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
-
Life expectancy ≥6 months as determined by the investigator
-
Able and willing to provide informed consent and comply with protocol requirements
Exclusion Criteria:
-
Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
-
Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
-
Treatment with ADT in the past 3 months of Day 1
-
Receipt of investigational therapy for prostate cancer within 60 days of Day 1
-
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | City of Hope National Medical Center | Duarte | California | United States | 91010 |
2 | Tower Urology | Los Angeles | California | United States | 90048 |
3 | University of California San Francisco - Helen Diller Cancer Center | San Francisco | California | United States | 94143 |
4 | Stanford | Stanford | California | United States | 94305 |
5 | Yale University | New Haven | Connecticut | United States | 06520 |
6 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
7 | University of Iowa | Iowa City | Iowa | United States | 52242 |
8 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
9 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
10 | Washington University - Mallinckrodt Institute of Radiology | Saint Louis | Missouri | United States | 63110 |
11 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
12 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
13 | University of Wisconsin | Madison | Wisconsin | United States | 53705 |
14 | Chu de Quebec - Universite Laval | Quebec | Canada | G1R2J6 |
Sponsors and Collaborators
- Progenics Pharmaceuticals, Inc.
Investigators
- Study Director: Jessica D Jensen, Progenics Pharmaceuticals, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.- PyL 3301
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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 |
Baseline Characteristics
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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 Participants | 208 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
68
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
208
100%
|
Race/Ethnicity, Customized (Count of Participants) | |
Asian |
3
1.4%
|
Black or African American |
15
7.2%
|
White |
188
90.4%
|
Other, including not reported |
2
1%
|
Outcome Measures
Title | Correct Localization Rate (CLR) |
---|---|
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. |
Outcome Measure Data
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 |
---|---|
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. |
Measure Participants | 208 |
Central Reader 1 |
85.6
41.2%
|
Central Reader 2 |
87.0
41.8%
|
Central Reader 3 |
84.8
40.8%
|
Title | Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. |
---|---|
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. |
Outcome Measure Data
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 |
---|---|
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. |
Measure Participants | 205 |
Count of Participants [Participants] |
131
63%
|
Title | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Set includes all participants who received any amount of 18F-DECPyL. |
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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. |
Measure Participants | 208 |
Systolic Blood Pressure: Baseline (actual) |
138.9
(18.61)
|
Systolic Blood Pressure: Post-dosing (actual) |
136.7
(17.15)
|
Systolic Blood Pressure: Change from Baseline |
-2.2
(13.24)
|
Diastolic Blood Pressure: Baseline (actual) |
78.5
(10.18)
|
Diastolic Blood Pressure: Post-dosing (actual) |
77.3
(9.57)
|
Diastolic Blood Pressure: Change from Baseline |
-1.2
(8.20)
|
Title | The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Set includes all participants who received any amount of 18F-DCFPyL. |
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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. |
Measure Participants | 208 |
Heart Rate: Baseline (actual) |
69.3
(12.75)
|
Heart Rate: Post-dosing (actual) |
65.1
(12.09)
|
Heart Rate: Change from Baseline |
-4.3
(7.93)
|
Title | Collection of Concomitant Medications (Safety Outcome Measure) |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Set includes all participants who received any amount of 18F-DCFPyL. |
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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. |
Measure Participants | 208 |
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%
|
Title | Collection of Medical Procedures (Safety Outcome Measure) |
---|---|
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. |
Outcome Measure Data
Analysis Population Description |
---|
The Safety Set includes all participants who received any amount of 18F-DCFPyL. |
Arm/Group Title | 18F-DCFPyL Injection |
---|---|
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. |
Measure Participants | 208 |
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%
|
Adverse Events
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 | ||
Arm/Group Title | 18F-DCFPyL Injection | |
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 (%) | # Events | |
Total | 0/208 (0%) | |
Serious Adverse Events |
||
18F-DCFPyL Injection | ||
Affected / at Risk (%) | # Events | |
Total | 1/208 (0.5%) | |
Immune system disorders | ||
Hypersensitivity | 1/208 (0.5%) | |
Nervous system disorders | ||
Headache | 1/208 (0.5%) | |
Paresthesia | 1/208 (0.5%) | |
Other (Not Including Serious) Adverse Events |
||
18F-DCFPyL Injection | ||
Affected / at Risk (%) | # Events | |
Total | 7/208 (3.4%) | |
General disorders | ||
Fatigue | 2/208 (1%) | |
Nervous system disorders | ||
Headache | 3/208 (1.4%) | |
Vascular disorders | ||
Hypertension | 2/208 (1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | David Myl |
---|---|
Organization | Lantheus Medical Imaging / Progenics Pharmaceuticals |
Phone | 914-582-1120 |
david.myl@lantheus.com |
- PyL 3301