- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03263780
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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
California
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 18F-Fluciclovine
10mCi +/-20% 18F-fluciclovine injection
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Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: 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+) |
At time of post-imaging biopsy
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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.
Tidsramme: 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+) |
At time of post-imaging biopsy
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Negative Biopsy Rate (Number of Participants With Negative Biopsy)
Tidsramme: 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.
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6 months following standard HIFU therapy
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Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
Tidsramme: 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.
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6 months following standard HIFU therapy
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Timothy Daskivich, MD, Cedars-Sinai Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT2016-19-DASKIVICH-18F
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