Prostate Adenocarcinoma, Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent
Conditions
Keywords
Positron emission tomography, biochemical recurrence, rising PSA, PET/CT, Diagnostic, Imaging, PSMA, radical prostatectomy, BCR
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.
Interventions
DRUG18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
DIAGNOSTIC_TESTPET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Sponsors
Progenics Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correct Localization Rate (CLR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. | 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) | 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) | 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) | 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) | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 208 |
| Total | 208 |
Baseline characteristics
| Characteristic | 18F-DCFPyL Injection |
|---|---|
| Age, Continuous | 68 years |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Other, including not reported | 2 Participants |
| Race/Ethnicity, Customized White | 188 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 208 |
| other Total, other adverse events | 7 / 208 |
| serious Total, serious adverse events | 1 / 208 |
Outcome results
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.
Time frame: Within 60 days following 18F-DCFPyL PET/CT imaging.
Population: Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-DCFPyL Injection | Correct Localization Rate (CLR) | Central Reader 3 | 84.8 percentage of participants |
| 18F-DCFPyL Injection | Correct Localization Rate (CLR) | Central Reader 1 | 85.6 percentage of participants |
| 18F-DCFPyL Injection | Correct Localization Rate (CLR) | Central Reader 2 | 87.0 percentage of participants |
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.
Time frame: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | HMG COA REDUCTASE INHIBITORS | 103 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | PLATELET AGGREGATION INHIBITORS (EXCLUDING HEPARIN) | 63 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | ACE INHIBITORS, PLAIN | 36 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | VITAMIN D AND ANALOGUES | 32 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | ANGIOTENSIN II ANTAGONISTS, PLAIN | 31 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | BETA BLOCKING AGENTS, SELECTIVE | 31 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | DIHYDROPYRIDINE DERIVATIVES | 31 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | PROPIONIC ACID DERIVATIVES | 12 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | THYROID HORMONES | 11 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE | 11 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | PROTEIN PUMP INHIBITORS | 29 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | DRUGS USED IN ERECTILE DYSFUNCTION | 23 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | MULTIVITAMINS, PLAIN | 18 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | BIGUANIDES | 17 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | THIAZIDES, PLAIN | 16 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | OTHER ANTIDEPRESSANTS | 15 Participants |
| 18F-DCFPyL Injection | Collection of Concomitant Medications (Safety Outcome Measure) | ALPHA-ADRENORECEPTOR ANTAGONISTS | 12 Participants |
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.
Time frame: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Biopsy testes | 1 Participants |
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Nuclear magnetic resonance imaging | 1 Participants |
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Ultrasound testes | 1 Participants |
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Open reduction of fracture | 1 Participants |
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Computerized tomogram | 1 Participants |
| 18F-DCFPyL Injection | Collection of Medical Procedures (Safety Outcome Measure) | Orchidectomy | 1 Participants |
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.
Time frame: Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
Population: Participants with a Medical Management Questionnaire (MMQ) completed at pre- and post- 18F-DCFPyL PET/CT imaging.
| Arm | Measure | Value (COUNT_OF_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 Participants |
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.
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.
Population: The Safety Set includes all participants who received any amount of 18F-DECPyL.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Systolic Blood Pressure: Baseline (actual) | 138.9 mmHg | Standard Deviation 18.61 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Systolic Blood Pressure: Post-dosing (actual) | 136.7 mmHg | Standard Deviation 17.15 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Systolic Blood Pressure: Change from Baseline | -2.2 mmHg | Standard Deviation 13.24 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Diastolic Blood Pressure: Baseline (actual) | 78.5 mmHg | Standard Deviation 10.18 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Diastolic Blood Pressure: Post-dosing (actual) | 77.3 mmHg | Standard Deviation 9.57 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) | Diastolic Blood Pressure: Change from Baseline | -1.2 mmHg | Standard Deviation 8.2 |
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.
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.
Population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) | Heart Rate: Post-dosing (actual) | 65.1 bpm | Standard Deviation 12.09 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) | Heart Rate: Change from Baseline | -4.3 bpm | Standard Deviation 7.93 |
| 18F-DCFPyL Injection | The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) | Heart Rate: Baseline (actual) | 69.3 bpm | Standard Deviation 12.75 |