IIT2020-14-Dagnolo-HIFU, Ph2, open label, prostate cancer, 18F-PSMA

Summary

This study focuses on individuals who have been diagnosed with high-grade prostate cancer localized to one lobe and are considering high-intensity, focused ultrasound (HIFU) therapy or who have elected to undergo radical prostatectomy. The purpose of the study is to evaluate the usefulness of new imaging technologies, DWI MRI and 18F-PSMA PET-MRI, in detecting biopsy-proven prostate cancers not seen on standard magnetic resonance imaging technologies (MRI).

DWI MRI is a high-resolution, diffusion-weighted MRI imaging technique. 18F-PSMA (prostate-specific membrane antigen) PET-MRI is an imaging method that uses a radioactive drug called 18F-DCFPyL Injection. Researchers believe that the combination of DWI MRI and 18F-PSMA PET-MRI may improve diagnostic accuracy in detecting prostate cancer lesions. The use of 18F-DCFPyL in this study is investigational.


Inclusion Criteria

  • Biopsy consisting of ≥ 10 tissue cores sampled
  • PSA <20 ng/mL (for HIFU arm only)
  • cT1-cT2c
  • Either overall Gleason score > 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core (for HIFU arm only)
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Study Location(s)

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

Full Title

IIT2020-14-DAGNOLO-HIFU: High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound Therapy or Radical Prostatectomy

Details
Disease Type/Condition

Prostate

Principal Investigator

D'Agnolo, Alessandro

Co-Investigators

Amit Gupta, Debiao Li, Hyung Kim, Rola Saouaf, Stephen Freedland, Timothy Daskivich, Yaniv Raphael

Age Group

Adult

Phase

II (Cancer Control)

IRB Number

STUDY00000832

ClinicalTrials.gov ID

NCT04461509

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Prostate

Principal Investigator

D'Agnolo, Alessandro

Age Group

Adult

Phase

II (Cancer Control)

IRB Number

IIT2020-14-DAGNOLO-HIFU

ClinicalTrials.gov ID

NCT04461509

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?