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Trial record 18 of 333 for:    prostate cancer AND MRI | ( Map: United States )

High Resolution PET-MRI Before Prostate Cancer HIFU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263780
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Timothy J. Daskivich, Cedars-Sinai Medical Center

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.

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

Detailed Description:

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 18F-Fluciclovine
10mCi +/-20% 18F-fluciclovine injection
Drug: 18F-Fluciclovine
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Other Names:
  • Axumin
  • prostate-cancer-specific radiotracer




Primary Outcome Measures :
  1. Number of biopsy-proven cancers that standard imaging (mpMRI) would have missed compared with high resolution diffusion-weighted imaging (DWI) PET-hrMRI on mapping MRI. [ Time Frame: At time of post-imaging biopsy ]
    Difference between sensitivities to identify prostate lesions.


Secondary Outcome Measures :
  1. Negative biopsy rate [ Time Frame: 6 months following standard HIFU therapy ]
    Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.

  2. Rate of high grade cancer [ Time Frame: 6 months following standard HIFU therapy ]
    Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.



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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 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

Exclusion Criteria:

  • 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.

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): NCT03263780


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Timothy J. Daskivich
Blue Earth Diagnostics
Investigators
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Principal Investigator: Timothy Daskivich, MD Cedars-Sinai Medical Center
  Study Documents (Full-Text)

Documents provided by Timothy J. Daskivich, Cedars-Sinai Medical Center:
Study Protocol  [PDF] March 10, 2017


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Responsible Party: Timothy J. Daskivich, Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03263780     History of Changes
Other Study ID Numbers: IIT2016-19-DASKIVICH-18F
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 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 Timothy J. Daskivich, Cedars-Sinai Medical Center:
Diagnostic imaging
High-Intensity Focused Ultrasound
HIFU
18F-Fluciclovine
high resolution diffusion-weighted imaging
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases