High Resolution PET-MRI Before Prostate Cancer HIFU

• Sponsor: Timothy J. Daskivich (Other)
• Overall Status: Completed
• CT.gov ID: NCT03263780
• Collaborator: Blue Earth Diagnostics (Industry)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• 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: Dec 7, 2017
• Actual Primary Completion Date: Jan 8, 2020
• Actual Study Completion Date: Jan 8, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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. [At time of post-imaging biopsy]

   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+)

2. 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. [At time of post-imaging biopsy]

   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+)

Secondary Outcome Measures

1. Negative Biopsy Rate (Number of Participants With Negative Biopsy) [6 months following standard 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). 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 (Number of Patients With High Grade Cancer) [6 months following standard 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). 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Timothy J. Daskivich
• Blue Earth Diagnostics

Investigators

• Principal Investigator: Timothy Daskivich, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 17, 2019

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: IIT2016-19-DASKIVICH-18F
• First Posted: Aug 28, 2017
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by 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: Diagnostic imaging; High-Intensity Focused Ultrasound; HIFU; 18F-Fluciclovine; high resolution diffusion-weighted imaging
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Recruitment Details	Opened to accrual on 12/07/2017 with first subject enrolled on study 12/18/2017. A total of 21 patients consented, one withdrew consent prior to intervention and was replaced, 13 were evaluable for primary outcome measure, however 11 subjects of the total target accrual of 20 subjects completed study with the last subject off treatment/off study as of 1/8/2020.

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
Period Title: Overall Study
STARTED	21
COMPLETED	11
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	10mCi +/-20% 18F-fluciclovine injection 18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 23.1%
>=65 years	10 76.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.8 (7.54)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	13 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	13 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 7.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 15.4%
White	10 76.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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+)
Time Frame	At time of post-imaging biopsy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
Measure Participants	13
Measure Total biopsy-proven cancers (Gleason 6+)	32
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	5
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	4
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments	mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 6+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.25
	Confidence Interval	(2-Sided) 95%; 0.19 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments	mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 6+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; 0.44 to 0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.060
	Comments	mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 6+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; 0.17 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.083
	Comments	mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 6+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; 0.39 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

2. Primary Outcome

Title	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.
Description	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+)
Time Frame	At time of post-imaging biopsy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
Measure Participants	13
Measure Total biopsy-proven cancers (Gleason 7+)	20
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.096
	Comments	mpMRI vs hrMRI and PET (PIRADS 3-5 & Gleason 7+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.317
	Comments	mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.66
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	18F-Fluciclovine
	Comments	mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.317
	Comments	mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+)
	Method	Durkalski's Chi-square test
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	0.60
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments	We did not present standard deviation as the variability is already incorporated in the provided confidence interval.

3. Secondary Outcome

Title	Negative Biopsy Rate (Number of Participants With Negative Biopsy)
Description	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.
Time Frame	6 months following standard HIFU therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
Measure Participants	13
Count of Participants [Participants]	11 84.6%

4. Secondary Outcome

Title	Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
Description	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.
Time Frame	6 months following standard HIFU therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
Measure Participants	11
Count of Participants [Participants]	1 7.7%

Adverse Events

Time Frame	Up to 6 months following standard HIFU therapy.
Arm/Group Title	18F-Fluciclovine
Arm/Group Description	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.
All Cause Mortality
	18F-Fluciclovine
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Serious Adverse Events
	18F-Fluciclovine
	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)
Infections and infestations
Sepsis	1/13 (7.7%)	2
Urinary tract infection	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	18F-Fluciclovine
	Affected / at Risk (%)	# Events
Total	0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.