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Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRI (Flucipro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02002455
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : October 21, 2016
GE Healthcare
Blue Earth Diagnostics
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Device: PET/CT, PET/MRI, mpMRI Phase 2

Detailed Description:

Specific aims of the current study are as follows:

i) To determine the sensitivity, specificity and accuracy of multiparametric 3T MRI, (anatomical MRI, DCE-MRI, DWI and 1H MRS) combined with FACBC PET/CT and PET/MRI in correlation with systematic biopsy and whole mount prostatectomy specimens.

ii) To asses the applicability of multiparametric 3T MRI combined with FACBC-PET/CT and PET/MRI for detection of cancer aggressiveness based on Gleason score and PSA.

iii) To develop quantitative and qualitative methods for evaluation of FACBC PET/MRI

iv) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging both for surgical and radiotherapy patients at Turku PET Centre using hybrid PET/MRI

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma
Study Start Date : December 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Multimodality imaging
Device: PET/CT, PET/MRI, mpMRI
FACBC dose 370 megabecquerel (MBq)

Primary Outcome Measures :
  1. Diagnostic accuracy of hybrid PET/MRI with FACBC [ Time Frame: 1 years ]
    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

Secondary Outcome Measures :
  1. Biochemical relapse free survival (bRFS) [ Time Frame: 5 years ]
    By sequential measurements of serum PSA bRFS will be determined in patients having biologically guided radiotherapy (BGRT) plans. BGRT is performed with dose painting of hot spots at PET/MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02002455

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Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
GE Healthcare
Blue Earth Diagnostics
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Principal Investigator: Heikki Minn, Professor Turku University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Heikki Minn, Professor, Turku University Hospital Identifier: NCT02002455    
Other Study ID Numbers: T70/2013
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heikki Minn, Turku University Hospital:
Radical prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases