A Phase 3 interventional study of 18F-DCFPyL and PET/CT Imaging in Prostate Cancer, Prostate Adenocarcinoma and Prostate Cancer Recurrent, sponsored by Progenics Pharmaceuticals, Inc.. Completed at 14 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Progenics Pharmaceuticals, Inc. · Phase 3, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 208 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Progenics Pharmaceuticals, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
Exclusion Criteria:
9 mCi (333 MBq) IV injection of 18F-DCFPyL
Drug: 18F-DCFPyL · Diagnostic Test: PET/CT Imaging
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
Also known as: PyL
PET/CT imaging will be acquired 1-2 hours post-PyL injection
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.
Time frame: Within 60 days following 18F-DCFPyL PET/CT imaging.
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.
Time frame: Pre 18F-DCFPyL PET/CT imaging and within 60 days following 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.
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 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.
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.
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.
Time frame: 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.
Time frame: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
| Milestone | 18F-DCFPyL Injection |
|---|---|
| Started | 208 |
| Completed | 195 |
| Not completed | 13 |
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.
| percentage of participants | 18F-DCFPyL Injection |
|---|---|
| Central Reader 1 | 85.6 (78.8 to 92.3) |
| Central Reader 2 | 87.0 (80.4 to 93.6) |
| Central Reader 3 | 84.8 (77.8 to 91.9) |
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 | 18F-DCFPyL Injection |
|---|---|
| Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. | 131 |
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
| mmHg | 18F-DCFPyL Injection |
|---|---|
| Systolic Blood Pressure: Baseline (actual) | 138.9 ± 18.61 |
| Systolic Blood Pressure: Post-dosing (actual) | 136.7 ± 17.15 |
| Systolic Blood Pressure: Change from Baseline | -2.2 ± 13.24 |
| Diastolic Blood Pressure: Baseline (actual) | 78.5 ± 10.18 |
| Diastolic Blood Pressure: Post-dosing (actual) | 77.3 ± 9.57 |
| Diastolic Blood Pressure: Change from Baseline | -1.2 ± 8.20 |
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
| bpm | 18F-DCFPyL Injection |
|---|---|
| Heart Rate: Baseline (actual) | 69.3 ± 12.75 |
| Heart Rate: Post-dosing (actual) | 65.1 ± 12.09 |
| Heart Rate: Change from Baseline | -4.3 ± 7.93 |
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.
| Participants | 18F-DCFPyL Injection |
|---|---|
| HMG COA REDUCTASE INHIBITORS | 103 |
| PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN) | 63 |
| ACE INHIBITORS, PLAIN | 36 |
| VITAMIN D AND ANALOGUES | 32 |
| ANGIOTENSIN II ANTAGONISTS, PLAIN | 31 |
| BETA BLOCKING AGENTS, SELECTIVE | 31 |
| DIHYDROPYRIDINE DERIVATIVES | 31 |
| PROTEIN PUMP INHIBITORS | 29 |
| DRUGS USED IN ERECTILE DYSFUNCTION | 23 |
| MULTIVITAMINS, PLAIN | 18 |
| BIGUANIDES | 17 |
| THIAZIDES, PLAIN | 16 |
| OTHER ANTIDEPRESSANTS | 15 |
| ALPHA-ADRENORECEPTOR ANTAGONISTS | 12 |
| PROPIONIC ACID DERIVATIVES | 12 |
| THYROID HORMONES | 11 |
| UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE | 11 |
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
| Participants | 18F-DCFPyL Injection |
|---|---|
| Biopsy testes | 1 |
| Computerized tomogram | 1 |
| Nuclear magnetic resonance imaging | 1 |
| Ultrasound testes | 1 |
| Open reduction of fracture | 1 |
| Orchidectomy | 1 |
Collected over Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18F-DCFPyL Injection | 0/208 (0%) | 1/208 (0.5%) | 7/208 (3.4%) |
| Event | 18F-DCFPyL Injection |
|---|---|
| HypersensitivityImmune system disorders | 1/208 |
| HeadacheNervous system disorders | 1/208 |
| ParesthesiaNervous system disorders | 1/208 |
| Event | 18F-DCFPyL Injection |
|---|---|
| HeadacheNervous system disorders | 3/208 |
| FatigueGeneral disorders | 2/208 |
| HypertensionVascular disorders | 2/208 |
Safety population; all participants who received any amount of 18F-DCFPyL
| Age, Continuous(years) | 18F-DCFPyL Injection |
|---|---|
| Median | 68 (43 to 91) |
| Sex: Female, Male(Participants) | 18F-DCFPyL Injection |
|---|---|
| Female | 0 |
| Male | 208 |
| Race/Ethnicity, Customized(Participants) | 18F-DCFPyL Injection |
|---|---|
| Asian | 3 |
| Black or African American | 15 |
| White | 188 |
| Other, including not reported | 2 |
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Progenics Pharmaceuticals, Inc.