Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02420977|
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : October 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Prostate Cancer||Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: DCFPyL PET-MRI fusion or PET/MRI
Drug: Pelvic DCFPyL PET-MRI fusion or PET/MRI
- Response rate differences [ Time Frame: baseline and after 2-3 months ]To compare the detection , sextant localization and response of DCFPyL PET-MRI fusion or PET/MRI before and after 2-3 months of ADT in men with biopsy-positive high-risk localized or locally advanced prostate cancer.
- Biomarker changes [ Time Frame: Baseline and at 2=3 months ]To compare DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of PSMA expression following ADT as determined by qualitative and quantitative MRI-guided prostate biopsy core tissue immunohistochemical analysis. DCFPyL uptake will also be compared to other prostate cancer relevant marker expression levels (PSA, Ki-67, TMPRSS2-ERG) by immunohistochemical analysis.
- Metabolic tumor uptake changes [ Time Frame: baseline and then at 2-3 months ]To compare DCFPyL PET-MRI fusion or PET/MRI uptake in primary prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) following ADT with standard clinical prognostic markers (PSA, Gleason score, clinical stage) and with predictive model of pathologic stage.
- Gene expression changes [ Time Frame: Baseline and then at 2-3 months ]To validate DCFPyL PET-MRI fusion or PET/MRI uptake in prostate cancer (quantified as per sextant SUVmax, SUVavg, metabolic tumor volume, total lesion DCFPyL uptake, DCFPyL uptake rate) as a reliable non-invasive imaging biomarker of AR signaling following ADT as determined by AR gene set expression of biopsy core tissue specimens using qPCR.
- Nodal metastatic disease changes [ Time Frame: Baseline and then at 2-3 months ]To compare the detection of nodal metastatic disease by DCFPyL PET-MRI fusion or PET/MRI at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and when available biopsy pathology.
- All cause DCFPyL PET-MRI fusion or PET/MRI toxicity [ Time Frame: Baseline and then at 2-3 months ]To determine the safety of DCFPyL.
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.
Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
- Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- Prostate biopsy histology grade ≥ Gleason 8-10
- Patients considered as candidates for and medically fit to undergo radiation and ADT
- At least 10 days after most recent prostate biopsy
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Hormone deprivation therapy
- Investigational therapy for prostate cancer
- Hemorrhagic cystitis or active prostatitis
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): NCT02420977
|Contact: Phuoc Tran, M.D., Ph.D.||(410) email@example.com|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Phuoc Tran, M.D., Ph.D. 410-614-3880 firstname.lastname@example.org|
|Contact: Terrence Caldwell (443) 287-1889 email@example.com|
|Sub-Investigator: Katarzyna Macura, M.D., Ph.D.|
|Sub-Investigator: Ronnie Mease, Ph.D.|
|Sub-Investigator: Georges Netto, M.D.|
|Sub-Investigator: Zsolt Szabo, M.D., Ph.D.|
|Sub-Investigator: Bruce Trock, Ph.D.|
|Sub-Investigator: Phuoc Tran, M.D., Ph.D.|
|Sub-Investigator: Martin Pomper, M.D., Ph.D.|
|Sub-Investigator: Edward Schaeffer, M.D., Ph.D.|
|Sub-Investigator: Danny Song, M.D.|
|Principal Investigator:||Theodore DeWeese, M.D.||The SKCCC at Johns Hopkins|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
IRB00065395 ( Other Identifier: JHM IRB )
1U01CA183031-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||April 20, 2015 Key Record Dates|
|Last Update Posted:||October 13, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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