High Resolution PET-MRI Before Prostate Cancer HIFU

NCT03263780 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IIT2016-19-DASKIVICH-18F
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.

Conditions

Prostate Cancer

Keywords

Diagnostic imaging; High-Intensity Focused Ultrasound; HIFU; 18F-Fluciclovine; high resolution diffusion-weighted imaging

Outcome Measures

Primary Outcomes (2)

• Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.

  A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)

  At time of post-imaging biopsy

• Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.

  A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)

  At time of post-imaging biopsy

Secondary Outcomes (2)

• Negative Biopsy Rate (Number of Participants With Negative Biopsy)

  6 months following standard HIFU therapy

• Rate of High Grade Cancer (Number of Patients With High Grade Cancer)

  6 months following standard HIFU therapy

Study Arms (1)

18F-Fluciclovine

EXPERIMENTAL

10mCi +/-20% 18F-fluciclovine injection

Drug: 18F-Fluciclovine

Interventions

18F-Fluciclovine DRUG

Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-Fluciclovine)

Also known as: Axumin, prostate-cancer-specific radiotracer

18F-Fluciclovine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate biopsy consisting of ≥ 10 tissue cores sampled
• PSA \</=20 ng/mL
• 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
• Patient considering focal HIFU therapy

You may not qualify if:

• Previous local therapy for prostate cancer
• Inability to receive PET tracer
• Inability to receive MRI
• Suggestion of extracapsular extension or seminal vesicle invasion on imaging
• Estimated creatinine clearance \<45 mL/min (Cockcroft-Gault equation)
• Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Sponsors & Collaborators

• Timothy J. Daskivich: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Timothy Daskivich, M.D.
• Organization: Cedars-Sinai Medical Center

timothy.daskivich@cshs.org

310-423-4700

Study Officials

• Timothy Daskivich, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 28, 2017
• Study Start: December 7, 2017
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (1)