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

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
18F-DCFPyL
PET/CT Imaging
Sponsored by
Progenics Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Positron emission tomography, biochemical recurrence, rising PSA, PET/CT, Diagnostic, Imaging, PSMA, radical prostatectomy, BCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • Tower Urology
  • University of California San Francisco - Helen Diller Cancer Center
  • Stanford
  • Yale University
  • Moffitt Cancer Center
  • University of Iowa
  • Johns Hopkins University
  • University of Michigan
  • Washington University - Mallinckrodt Institute of Radiology
  • Memorial Sloan Kettering Cancer Center
  • University of Pennsylvania
  • University of Wisconsin
  • Chu de Quebec - Universite Laval

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL Injection

Arm Description

9 mCi (333 MBq) IV injection of 18F-DCFPyL

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 9, 2018
Last Updated
June 10, 2021
Sponsor
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03739684
Brief Title
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic
Keywords
Positron emission tomography, biochemical recurrence, rising PSA, PET/CT, Diagnostic, Imaging, PSMA, radical prostatectomy, BCR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL Injection
Arm Type
Experimental
Arm Description
9 mCi (333 MBq) IV injection of 18F-DCFPyL
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL
Other Intervention Name(s)
PyL
Intervention Description
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT Imaging
Intervention Description
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Primary Outcome Measure Information:
Title
Correct Localization Rate (CLR)
Description
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.
Time Frame
Within 60 days following 18F-DCFPyL PET/CT imaging.
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
Description
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.
Time Frame
Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
Title
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
Description
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
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.
Title
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Description
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
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.
Title
Collection of Concomitant Medications (Safety Outcome Measure)
Description
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.
Time Frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Title
Collection of Medical Procedures (Safety Outcome Measure)
Description
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Time Frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only males subjects will be enrolled in this study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica D Jensen
Organizational Affiliation
Progenics Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California San Francisco - Helen Diller Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University - Mallinckrodt Institute of Radiology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Chu de Quebec - Universite Laval
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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