PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03232164|
Recruitment Status : Suspended (Due to COVID-19)
First Posted : July 27, 2017
Last Update Posted : June 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Neoplasm||Drug: 18F-DCFPyL PET||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single center, open label, single-arm, pilot study|
|Masking:||None (Open Label)|
|Official Title:||PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer|
|Actual Study Start Date :||February 2, 2017|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: 18F-DCFPyL PET
We will have three separate sub-studies evaluating 18F-DCFPyL PET imaging of prostate cancer in three prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, and (3) androgen-resistant metastatic disease.
Drug: 18F-DCFPyL PET
18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
- 18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for sub-study #1: Primary Prostate Cancer [ Time Frame: Up to 12 months ]To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.
- Evaluate 18F-DCFPyL PSMA-based PET for localization for sub-study #2: Biochemical Recurrence [ Time Frame: Up to 12 months ]To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). PSA response to prostatic fossa salvage irradiation will be compared with pre-salvage 18F-DCFPyL PET uptake in the radiation field.
- Compare detectability of 18F-DCFPyL for sub-study #3: Metastatic Androgen-Resistant Prostate Cancer [ Time Frame: Up to 12 months ]To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer.
- Sub-study #1: Detection of local-nodal and distant metastatic disease (PET [ Time Frame: Up to 12 months ]Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
- Sub-study #1: Correlation of 18F-DCFPyL PET and MRI [ Time Frame: Up to 12 months ]Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
- Sub-study #1: Specificity of 18F-DCFPyL [ Time Frame: Up to 12 months ]Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
- Sub-study #1: Low-dose CT versus MRI derived PET SUV [ Time Frame: Up to 12 months ]Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
- Sub-study #2: Detection of local-nodal and distant metastatic disease (pelvic) [ Time Frame: Up to 12 months ]Comparison of whole body 18F-DCFPyL PET with pelvic MR-MRI and whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
- Sub-study #2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI [ Time Frame: Up to 12 months ]Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.
- Sub-study #3: Contribution of whole body MRI DWI [ Time Frame: Up to 12 months ]Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.
- Sub-study #3: Quantitative accuracy [ Time Frame: Up to 12 months ]Assess the quantitative accuracy of 18F-DCFPyL PET standardized uptake value parameters from PET/MRI versus PET/CT.
- Sub-study #3: Quantitative reproducibility [ Time Frame: Up to 12 months ]Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232164
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Steve Y Cho, MD||University of Wisconsin, Madison|