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

• 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: Progenics Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Progenics Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: November 9, 2018
• First Posted Date: November 14, 2018
• Results First Submitted Date: May 16, 2021
• Results First Posted Date: June 14, 2021
• Last Update Posted Date: June 14, 2021
• Actual Study Start Date: November 27, 2018
• Actual Primary Completion Date: August 29, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Cancer Recurrent
• Prostate Cancer Metastatic

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 3, 2020): 208
• Original Estimated Enrollment (submitted: November 9, 2018): 200
• Actual Study Completion Date: August 29, 2019
• Actual Primary Completion Date: August 29, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only males subjects will be enrolled in this study.

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03739684
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Progenics Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Progenics Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Progenics Pharmaceuticals, Inc.
• Verification Date: June 2021