Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer (CONDOR)
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| ClinicalTrials.gov Identifier: NCT03739684 |
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Recruitment Status :
Completed
First Posted : November 14, 2018
Results First Posted : June 14, 2021
Last Update Posted : June 14, 2021
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Sponsor:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
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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 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
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: 18F-DCFPyL Injection
9 mCi (333 MBq) IV injection of 18F-DCFPyL
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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 |
Primary Outcome Measures :
- 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 :
- 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.
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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
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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
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
| 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
| Study Director: | Jessica D Jensen | Progenics Pharmaceuticals, Inc. |
Study Documents (Full-Text)
Documents provided by Progenics Pharmaceuticals, Inc.:
Documents provided by Progenics Pharmaceuticals, Inc.:
Study Protocol [PDF] July 31, 2018
Statistical Analysis Plan [PDF] October 24, 2019
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Progenics Pharmaceuticals, Inc.:
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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 Prostatic Diseases Disease Attributes Pathologic Processes |