Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 8/30/2018 |
| Start Date: | September 11, 2012 |
| End Date: | September 17, 2017 |
Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
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).
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).
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
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