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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Fluciclovine | Experimental | 10mCi +/-20% 18F-fluciclovine injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluciclovine | Drug | Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Biopsy Rate (Number of Participants With Negative 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). 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Daskivich, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 18F-Fluciclovine | 10mCi +/-20% 18F-fluciclovine injection 18F-Fluciclovine: Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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+) | Posted | Number | Total biopsy-proven cancers (Gleason 6+) | At time of post-imaging biopsy | Total biopsy-proven cancers (Gleason 6+) | Total biopsy-proven cancers (Gleason 6+) |
Up to 6 months following standard HIFU therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Daskivich, M.D. | Cedars-Sinai Medical Center | 310-423-4700 | timothy.daskivich@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2019 | Dec 17, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
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| 6 months following standard HIFU therapy |
| Rate of High Grade Cancer (Number of Patients With High Grade Cancer) | 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. | 6 months following standard HIFU therapy |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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. |
|
|
|
| Primary | 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+) | Posted | Number | Total biopsy-proven cancers (Gleason 7+) | At time of post-imaging biopsy | Total biopsy-proven cancers (Gleason 7+) | Total biopsy-proven cancers (Gleason 7+) |
|
|
|
|
| Secondary | Negative Biopsy Rate (Number of Participants With Negative 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). 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. | Posted | Count of Participants | Participants | 6 months following standard HIFU therapy |
|
|
|
| Secondary | Rate of High Grade Cancer (Number of Patients With High Grade Cancer) | 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. | Posted | Count of Participants | Participants | 6 months following standard HIFU therapy |
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 0 |
| 13 |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5) |
|
mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+) |
| Durkalski's Chi-square test |
| 0.317 |
mpMRI vs hrMRI or PET (PIRADS 3-5 & Gleason 7+) |
| Sensitivity |
| 0.60 |
| 2-Sided |
| 95 |
| 0.46 |
| 0.90 |
We did not present standard deviation as the variability is already incorporated in the provided confidence interval. |
| Superiority |
| mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) | Durkalski's Chi-square test | 0.063 | mpMRI vs hrMRI and PET (PIRADS 4-5 & Gleason 7+) | Sensitivity | 0.30 | 2-Sided | 95 | 0.23 | 0.66 | We did not present standard deviation as the variability is already incorporated in the provided confidence interval. | Superiority |
| mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+) | Durkalski's Chi-square test | 0.317 | mpMRI vs hrMRI or PET (PIRADS 4-5 & Gleason 7+) | Sensitivity | 0.60 | 2-Sided | 95 | 0.46 | 0.90 | We did not present standard deviation as the variability is already incorporated in the provided confidence interval. | Superiority |