Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Body Weight

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

18F-Fluciclovine

Timothy Daskivich, MD

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.

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.

High Resolution PET-MRI Before Prostate Cancer HIFU

High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy

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+)

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+)

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). 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.

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). 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.

Blue Earth Diagnostics

Timothy J. Daskivich

Staff Physician I, Division of Urology; Urologic Oncologist; Director, Health Services Research, Department of Surgery Cedars Sinai Medical Center

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

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

Prior to HIFU therapy, all subjects undergo mapping MRI using both standard mpMRI and experimental diffusion-weighted imaging (DWI) PET-hrMRI with 18F-Fluciclovine. PET scans involve injection of the radioisotope or tracer, where all subjects will receive 10mCi +/-20% 18F-fluciclovine injection, diluted up to 10mL injected via the IV, as an IV bolus injection followed by 10mL flush with normal saline solution.

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

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

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Timothy Daskivich, M.D.

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+)

Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)

Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)

Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)

Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)

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.

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+)

Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)

Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)

Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)

Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)

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.

Spots Global Cancer Trial Database for High Resolution PET-MRI Before Prostate Cancer HIFU

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Study Description

Keywords

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