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

June 10, 2021 updated by: Progenics Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R2J6
        • CHU de Québec - Université Laval
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • San Francisco, California, United States, 94143
        • University of California San Francisco - Helen Diller Cancer Center
      • Stanford, California, United States, 94305
        • Stanford
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University - Mallinckrodt Institute of Radiology
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct Localization Rate (CLR)
Time Frame: 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.
Within 60 days following 18F-DCFPyL PET/CT imaging.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
Time Frame: 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.
Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
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.
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.
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
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.
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.
Collection of Concomitant Medications (Safety Outcome Measure)
Time Frame: 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.
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Collection of Medical Procedures (Safety Outcome Measure)
Time Frame: 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.
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progenics Pharmaceuticals, Inc.

Investigators

  • Study Director: Jessica D Jensen, Progenics Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 27, 2018

Primary Completion (ACTUAL)

August 29, 2019

Study Completion (ACTUAL)

August 29, 2019

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PyL 3301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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