- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01967862
Fluor F 18 Natriumfluorid PET/CT og MRI af hele kroppen og aksial til at finde metastaser hos patienter med tilbagevendende prostatakræft
F18 NaF PET/CT og helkrops- og aksial MR til påvisning af metastaser hos patienter med biokemisk recidiv af prostatacancer
This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Andet: laboratory biomarker analysis
- Procedure: computed tomography
- Procedure: bone scan
- Procedure: 3-Tesla magnetic resonance imaging
- Procedure: diffusion-weighted magnetic resonance imaging
- Stråling: fluorine F 18 sodium fluoride
- Procedure: computed tomography
- Procedure: positron emission tomography
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.
SECONDARY OBJECTIVES:
I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.
II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.
III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.
IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.
OUTLINE:
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
After completion of study, patients are followed up at 4-6 months and periodically until week 52.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
South Pasadena, California, Forenede Stater, 91030
- City of Hope South Pasadena
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- History of prior radical prostatectomy for prostate cancer
- Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy
- Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Exclusion Criteria:
- Patients with known metastatic disease
- PSA recurrence not verified by elevated PSA as discussed in the eligibility section
- Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan. |
Correlative studies Undergo CT
Andre navne:
Undergo bone scan Undergo axial MRI
Andre navne:
Undergo WB MRI
Andre navne:
Undergo fluorine F 18 sodium fluoride PET/CT
Andre navne:
Undergo fluorine F 18 sodium fluoride PET/CT
Andre navne:
Undergo fluorine F 18 sodium fluoride PET/CT
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan.
Tidsramme: Up to 12 months
|
Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. |
Up to 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cy Stein, MD, PhD, City of Hope 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 (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Undersøgelsesteknikker
- Kemiteknikker, analytisk
- Spektrumanalyse
- Magnetisk resonansspektroskopi
- 2-phenyl-6- (2 '-(4'-(ethoxycarbonyl) thiazolyl)) thiazolo (3,2-B) (1,2,4) triazol
Andre undersøgelses-id-numre
- 13365
- NCI-2013-01924 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 13365 (Anden identifikator: City of Hope Medical Center)
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