Prostate Cancer
Conditions
Keywords
Primary Prostate Cancer
Brief summary
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC), as a PET imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available. Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (CT, bone scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived prediction of pathologic stage).
Interventions
DRUG18F-DCFBC
A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy 2. Prostate biopsy histology grade ≥ Gleason 3+3=6. 3. Patients considered as candidates for and medically fit to undergo prostatectomy 4. At least 10 days after most recent prostate biopsy 5. No known problems with peripheral IV or central line access 6. Able to tolerate urinary straight catheter placement 7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits. 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
Exclusion criteria
1. Prior pelvic external beam radiation therapy or brachytherapy 2. Chemotherapy for prostate cancer 3. Hormone deprivation therapy 4. Investigational therapy for prostate cancer 5. Hemorrhagic cystitis or active prostatitis 6. Unable to lie flat during or tolerate PET/CT 7. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer 8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging) 9. Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET Detection of Primary Prostate Cancer | 24 months | To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score \> 4+3=7). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PET Detection of Metastatic Disease at Initial Staging | 24 months | To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology. |
Countries
United States
Participant flow
Pre-assignment details
2 enrolled participants were screen failures, therefore 13 started the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Primary Prostate Cancer Patients will be imaged with 18F-DCFBC
18F-DCFBC: A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Patients With Primary Prostate Cancer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Biopsy Gleason Score Gleason score 3+3 | 1 Participants | — |
| Biopsy Gleason Score Gleason Score 3+4 | 5 Participants | — |
| Biopsy Gleason Score Gleason Score 4+3 | 4 Participants | — |
| Biopsy Gleason Score Gleason Score 4+4 | 3 Participants | — |
| Prostatectomy gleason score Gleason 3+3 | 1 Participants | — |
| Prostatectomy gleason score Gleason 3+4 | 5 Participants | — |
| Prostatectomy gleason score Gleason 4+3 | 2 Participants | — |
| Prostatectomy gleason score Gleason 4+4 | 1 Participants | — |
| Prostatectomy gleason score Gleason 4+5 | 3 Participants | — |
| Prostatectomy gleason score Gleason 5+3 | 1 Participants | — |
| Prostate specific antigen (PSA) | 8.36 ng/mL STANDARD_DEVIATION 3.77 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
PET Detection of Primary Prostate Cancer
To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score \> 4+3=7).
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Primary Prostate Cancer | PET Detection of Primary Prostate Cancer | Prostate Cancer with Positive Uptake of 18F-DCFBC | 6 Participants |
| Patients With Primary Prostate Cancer | PET Detection of Primary Prostate Cancer | Prostate Cancer with Negative Uptake of 18F-DCFBC | 7 Participants |
Secondary
PET Detection of Metastatic Disease at Initial Staging
To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.
Time frame: 24 months
Population: Data was not collected for this outcome measure.