Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 14, 2018
Results First Submitted Date  ICMJE May 16, 2021
Results First Posted Date  ICMJE June 14, 2021
Last Update Posted Date June 14, 2021
Actual Study Start Date  ICMJE November 27, 2018
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Correct Localization Rate (CLR), defined as percentage of subjects 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. [ Time Frame: Within 60 days following PyL PET/CT imaging. ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
Percentage of subjects with a change in intended prostate cancer treatment plans due to 18F-DCFPyL PET/CT imaging results. [ Time Frame: Pre-PyL imaging and within 60 days following PyL imaging. ]
The change in intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after PyL PET/CT imaging.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer Recurrent
  • Prostate Cancer Metastatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: 18F-DCFPyL Injection
9 mCi (333 MBq) IV injection of 18F-DCFPyL
Interventions:
  • Drug: 18F-DCFPyL
  • Diagnostic Test: PET/CT Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2020)
208
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
200
Actual Study Completion Date  ICMJE August 29, 2019
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only males subjects will be enrolled in this study.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03739684
Other Study ID Numbers  ICMJE PyL 3301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Progenics Pharmaceuticals, Inc.
Study Sponsor  ICMJE Progenics Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jessica D Jensen Progenics Pharmaceuticals, Inc.
PRS Account Progenics Pharmaceuticals, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP