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PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03232164
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Neoplasm Drug: 18F-DCFPyL PET Early Phase 1

Detailed Description:
The investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection of primary and metastatic prostate cancer. 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). The investigators propose to evaluate this PET agent for three different prostate cancer clinical scenarios: (1) detection of clinically significant high-grade prostate cancer and initial staging, (2) detection of sites of recurrence in the setting of biochemical recurrence after definitive prostatectomy, and (3) detection of advanced androgen-resistant metastatic prostate cancer.

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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)
Primary Purpose: Diagnostic
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, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for sub-study #1)
  • Prostate biopsy histology grade ≥ Gleason 6, positive biopsy >2 cores.
  • PSA > 0.2 ng/mL for Sub-study #2 or >1.0 ng/mL for Sub-study #3
  • Patients considered as candidates for and medically fit to undergo prostatectomy
  • At least 7 days after most recent prostate biopsy
  • Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-study #3 only)

Exclusion Criteria:

  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Hormone deprivation therapy
  • Investigational therapy for prostate cancer
  • Unable to lie flat during or tolerate PET/CT
  • 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.
  • No prostatectomy scheduled more than 12 hours post imaging
  • Serum creatinine > 2 time the upper limit of normal
  • Total bilirubin > 3 times the upper limit of normal
  • Liver Transaminases > 5 times the upper limit of normal

Information from the National Library of Medicine

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


Contacts
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Contact: Gemma Gliori (608) 262-7269 ggliori@uwhealth.org
Contact: Suzanne Hanson (608) 263-7421 shanson@uwhealth.org

Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Gemma Gliori    608-262-7269    ggliori@uwhealth.org   
Principal Investigator: Steve Y Cho, MD         
Sub-Investigator: David F Jarrard, MD         
Sub-Investigator: Mark A Ritter, MD         
Sub-Investigator: Glenn Liu, MD         
Sub-Investigator: Joshua M Lang, MD         
Sub-Investigator: Scott B Perlman, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steve Y Cho, MD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03232164     History of Changes
Other Study ID Numbers: UW16062
P30CA014520 ( U.S. NIH Grant/Contract )
2016-0883 ( Other Identifier: Institutional Review Board )
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Prostate Cancer
Prostate neoplasm
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases