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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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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
Prostate Cancer Prostate Adenocarcinoma Prostate Cancer Recurrent Prostate Cancer Metastatic Drug: 18F-DCFPyL Diagnostic Test: PET/CT Imaging Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : August 29, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: PyL

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males subjects will be enrolled in this study.
Accepts Healthy Volunteers:   No
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:

    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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739684


Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Tower Urology
Los Angeles, California, United States, 90048
University of California San Francisco - Helen Diller Cancer Center
San Francisco, California, United States, 94143
Stanford
Stanford, California, United States, 94305
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University - Mallinckrodt Institute of Radiology
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Canada
Chu de Quebec - Universite Laval
Quebec, Canada, G1R2J6
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
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Study Director: Jessica D Jensen Progenics Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Progenics Pharmaceuticals, Inc.:
Study Protocol  [PDF] July 31, 2018
Statistical Analysis Plan  [PDF] October 24, 2019

More Information
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Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03739684    
Other Study ID Numbers: PyL 3301
First Posted: November 14, 2018    Key Record Dates
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Progenics Pharmaceuticals, Inc.:
Positron emission tomography
biochemical recurrence
rising PSA
PET/CT
Diagnostic
 Imaging
PSMA
radical prostatectomy
BCR
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Disease Attributes
Pathologic Processes