Trial Outcomes & Findings for High Resolution PET-MRI Before Prostate Cancer HIFU (NCT NCT03263780)

Last Updated: 2021-02-21

Results Overview

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+)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

At time of post-imaging biopsy

Results posted on

2021-02-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	18F-Fluciclovine 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.
Overall Study STARTED	21
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	18F-Fluciclovine 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.
Overall Study Withdrawal by Subject	3
Overall Study Ineligible (incomplete post-HIFU)	7

Baseline Characteristics

High Resolution PET-MRI Before Prostate Cancer HIFU

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-Fluciclovine n=13 Participants 10mCi +/-20% 18F-fluciclovine injection 18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging \[DWI\] MRI with 18F-Fluciclovine)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	67.8 years STANDARD_DEVIATION 7.54 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of post-imaging biopsy

Outcome measures

Outcome measures
Measure	18F-Fluciclovine n=32 Total biopsy-proven cancers (Gleason 6+) 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.
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. Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	5 Total biopsy-proven cancers (Gleason 6+)
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. Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1 Total biopsy-proven cancers (Gleason 6+)
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. Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	4 Total biopsy-proven cancers (Gleason 6+)
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. Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1 Total biopsy-proven cancers (Gleason 6+)

PRIMARY outcome

Timeframe: 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+)

Outcome measures

Outcome measures
Measure	18F-Fluciclovine n=20 Total biopsy-proven cancers (Gleason 7+) 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.
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. Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	1 Total biopsy-proven cancers (Gleason 7+)
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. Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1 Total biopsy-proven cancers (Gleason 7+)
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. Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	1 Total biopsy-proven cancers (Gleason 7+)
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. Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1 Total biopsy-proven cancers (Gleason 7+)

SECONDARY outcome

Timeframe: 6 months following standard HIFU therapy

Outcome measures

Outcome measures
Measure	18F-Fluciclovine n=13 Participants 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.
Negative Biopsy Rate (Number of Participants With Negative Biopsy)	11 Participants

SECONDARY outcome

Timeframe: 6 months following standard HIFU therapy

Outcome measures

Outcome measures
Measure	18F-Fluciclovine n=11 Participants 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.
Rate of High Grade Cancer (Number of Patients With High Grade Cancer)	1 Participants

Adverse Events

18F-Fluciclovine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	18F-Fluciclovine n=13 participants at risk 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.
Infections and infestations Sepsis	7.7% 1/13 • Number of events 2 • Up to 6 months following standard HIFU therapy.
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • Up to 6 months following standard HIFU therapy.

Other adverse events

Adverse event data not reported

Additional Information

Timothy Daskivich, M.D.

Cedars-Sinai Medical Center

Phone: 310-423-4700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place