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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL Injection | Experimental | 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL | Drug | A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 60 days following 18F-DCFPyL PET/CT imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging. |
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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:
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:
Only males subjects will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica D Jensen | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Tower Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41806372 | Derived | Agarwal G, Sangwan K. FDA-Approved Radiopharmaceuticals in Oncologic PET Imaging: Current Status and Clinical Impact. Am J Clin Oncol. 2026 Mar 4. doi: 10.1097/COC.0000000000001314. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18F-DCFPyL Injection | Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2018 | May 16, 2021 |
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| PET/CT Imaging | Diagnostic Test | PET/CT imaging will be acquired 1-2 hours post-PyL injection |
|
| 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. | 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 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. | 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. |
| 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. | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. |
| 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. | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California San Francisco - Helen Diller Cancer Center | San Francisco | California | 94143 | United States |
| Stanford | Stanford | California | 94305 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University - Mallinckrodt Institute of Radiology | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Chu de Quebec - Universite Laval | Québec | G1R2J6 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Safety population; all participants who received any amount of 18F-DCFPyL
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-DCFPyL Injection | Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 60 days following 18F-DCFPyL PET/CT imaging. |
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| Secondary | 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. | Participants with a Medical Management Questionnaire (MMQ) completed at pre- and post- 18F-DCFPyL PET/CT imaging. | Posted | Count of Participants | Participants | Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging. |
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| Secondary | 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 Safety Set includes all participants who received any amount of 18F-DECPyL. | Posted | Mean | Standard Deviation | mmHg | 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. |
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| Secondary | 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. | The Safety Set includes all participants who received any amount of 18F-DCFPyL. | Posted | Mean | Standard Deviation | bpm | 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. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set includes all participants who received any amount of 18F-DCFPyL. | Posted | Count of Participants | Participants | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. |
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| Secondary | 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. | The Safety Set includes all participants who received any amount of 18F-DCFPyL. | Posted | Count of Participants | Participants | From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing. |
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Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-DCFPyL Injection | Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing. | 0 | 208 | 1 | 208 | 7 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Non-systematic Assessment |
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Study results cannot be published before the earlier of a multi-site publication; or 18 months after the end of the Study at all sites; or confirmation by Sponsor that there will be no multi-site publication. The proposed publication must be submitted to Sponsor at least 60 days prior to publication so that Sponsor can delete Sponsor Confidential Information (other than Study results) and obtain a further 60 days to file on any invention disclosed in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Myl | Lantheus Medical Imaging / Progenics Pharmaceuticals | 914-582-1120 | david.myl@lantheus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2019 | May 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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| White |
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| Other, including not reported |
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