Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma With PET and MRI
Condition: Prostate Carcinoma
MeSH terms: Carcinoma; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

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.
    

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
    

Intervention name(s): PET/CT, PET/MRI, mpMRI
Intervention type(s): Device
Intervention description(s): FACBC dose 370 megabecquerel (MBq)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: FACBC; PET/CT; PET/MRI; Radical prostatectomy; Radiotherapy