Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRI
Flucipro
1 other identifier
interventional
26
1 country
1
Brief Summary
Prostate cancer (PCa) is currently the most common neoplastic disease among men in well-developed countries with 350 000 new cases diagnosed annually in Europe and 4 800 in Finland. Due to widespread use of serum prostate specific antigen (PSA) in asymptomatic men, most patients present initially with localized disease. Radical prostatectomy, radiotherapy (RT) and active surveillance are the most common management options for patients with localized PCa. Proper preoperative staging for patients with adverse features on biopsy who are candidates for radical prostatectomy is urgently needed. For elderly men external beam RT is the preferred modality which can be safely performed utilizing modern techniques such as intensity modulated and image guided radiotherapy (IMRT and IGRT). Since randomized studies suggest a dose response effect beyond 78-80 Gy newer techniques aim at dose escalation provided that toxicity can be controlled. Therefore, ultra high dose IMRT/IGRT requires visualization of intracapsular disease which will receive the highest dose. Taken together, the use of accurate anatomical and functional imaging modalities are essential for planning both nerve sparing radical prostatectomy and ultra high dose IMRT/IGRT Fluorine-18 labeled L-leucine analogue 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) has shown to preferentially accumulate in PCa and its nodal metastases. By assisting in localization of intraprostatic and pelvic disease FACBC with hybrid positron emission tomography/computed tomography (PET/CT) or magnetic resonance imaging (PET/MRI) has potential to improve selection of patients for robot-assisted radical prostatectomy and IMRT/IGRT. Anatomical MRI at 1.5 Tesla (T) compared with transrectal ultrasound has demonstrated a higher sensitivity for tumor detection but almost the same specificity, stressing the need for additional metabolic MRI. Advanced application of MRI such as proton magnetic resonance spectroscopy (1H MRS), diffusion weighted imaging (DWI) and dynamic contrast enhanced imaging (DCE-MRI) are increasingly being used for detection and characterization of PCa. The use of 3T scanners and multiparametric MRI (mpMRI), consisting of anatomical MRI, DWI, 1H MRS and DCE-MRI, demonstrated very promising result for staging and detection of PCa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 21, 2016
October 1, 2016
2.4 years
November 29, 2013
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of hybrid PET/MRI with FACBC
By comparing tracer uptake and imaging findings at MRI in each sextant with macroslices obtained at radical prostatectomy sensitivity, specificity, positive and negative predictive value and accuracy will be calculated
1 years
Secondary Outcomes (1)
Biochemical relapse free survival (bRFS)
5 years
Study Arms (1)
Multimodality imaging
EXPERIMENTALPET/CT, PET/MRI, mpMRI
Interventions
Eligibility Criteria
You may qualify if:
- Age: 50 to 85 years old
- Language spoken: Finnish or Swedish
- Diagnosis: Histologically confirmed adenocarcinoma of prostate
- Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
- No previous surgical, radiation or endocrine treatment for prostate carcinoma
- Clinical stage T1c-T3aN0 based on transrectal ultrasound
- Serum creatinine ≤ 1,5 x upper limit of normal (ULN)
- Patient agrees to undergo either surgery or external radiotherapy
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
You may not qualify if:
- Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
- Infections: Patient must not have an uncontrolled serious infection
- No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Patient preference for active surveillance as a method of prostate cancer management
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- GE Healthcarecollaborator
- Blue Earth Diagnosticscollaborator
Study Sites (1)
Turku University Hospital
Turku, 20521, Finland
Related Publications (1)
Jambor I, Kuisma A, Kahkonen E, Kemppainen J, Merisaari H, Eskola O, Teuho J, Perez IM, Pesola M, Aronen HJ, Bostrom PJ, Taimen P, Minn H. Prospective evaluation of 18F-FACBC PET/CT and PET/MRI versus multiparametric MRI in intermediate- to high-risk prostate cancer patients (FLUCIPRO trial). Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):355-364. doi: 10.1007/s00259-017-3875-1. Epub 2017 Nov 16.
PMID: 29147764DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heikki Minn, Professor
Turku University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 29, 2013
First Posted
December 5, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
October 21, 2016
Record last verified: 2016-10