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

Prostate Cancer Clinical Trial

— CONDOR  

Official title:

A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739684
• Other study ID #: PyL 3301
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: June 2021
• Source: Progenics Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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:

1. 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

2. 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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Metastatic
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

Intervention

Drug:
• 18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL

Diagnostic Test:
• PET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection

Locations

Country	Name	City	State
Canada	Chu de Quebec - Universite Laval	Quebec
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	City of Hope National Medical Center	Duarte	California
United States	University of Iowa	Iowa City	Iowa
United States	Tower Urology	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University - Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	University of California San Francisco - Helen Diller Cancer Center	San Francisco	California
United States	Stanford	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Progenics Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct Localization Rate (CLR)	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.	Within 60 days following 18F-DCFPyL PET/CT imaging.
Secondary	Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.	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.	Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
Secondary	The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)	The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.	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.
Secondary	The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)	The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.	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.
Secondary	Collection of Concomitant Medications (Safety Outcome Measure)	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.	From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Secondary	Collection of Medical Procedures (Safety Outcome Measure)	Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.	From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.