Prostate Cancer
Conditions
Brief summary
This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.
Detailed description
This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.
Interventions
DRUG18F-DCFPyL
18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Sponsors
Progenics Pharmaceuticals, Inc.
Ashok Muthukrishnan
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
* Histologically confirmed diagnosis of prostate cancer * Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition) * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Ability to understand and willingness to sign a written informed consent document * Willing to comply with clinical trial instructions and requirements
Exclusion criteria
* History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin * Presence of prostate brachytherapy implants unless approved by the PI * Administration of another radioisotope within five physical half-lives of trial enrollment * Radiation or chemotherapy within 2 weeks prior to trial enrollment * Estimated glomerular filtration rate (eGFR) \< 15 ml/mmol * Serum total bilirubin \> 3 times the upper limit of normal * Aspartate transaminase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal * Inadequate venous access * Claustrophobia or any other condition that would preclude PET imaging * Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL. * Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) (Per-patient) | Up to 12 months | Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) (Per-region) | Up to 12 months | Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 18F-DCFPyL + PET Imaging Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study.
(The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.)
18F-DCFPyL: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | 18F-DCFPyL + PET Imaging |
|---|---|
| Age, Continuous | 67 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Positive Predictive Value (PPV) (Per-patient)
Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
Time frame: Up to 12 months
Population: Male patients diagnosed with prostate cancer with increasing PSA levels.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-DCFPyL + PET Imaging | Positive Predictive Value (PPV) (Per-patient) | 83.9 Per-patient percentage |
Secondary
Positive Predictive Value (PPV) (Per-region)
Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.
Time frame: Up to 12 months
Population: Male patients diagnosed with prostate cancer with increasing PSA levels.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-DCFPyL + PET Imaging | Positive Predictive Value (PPV) (Per-region) | In prostate bed | 50 percentage per anatomical region |
| 18F-DCFPyL + PET Imaging | Positive Predictive Value (PPV) (Per-region) | In LN pelvis | 96 percentage per anatomical region |
| 18F-DCFPyL + PET Imaging | Positive Predictive Value (PPV) (Per-region) | In LN extra-pelvis | 80 percentage per anatomical region |
| 18F-DCFPyL + PET Imaging | Positive Predictive Value (PPV) (Per-region) | In bone lesions | 85.7 percentage per anatomical region |