Clinical Trial · NCT02002455

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

Overview

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.

Sponsor

Turku University Hospital

Phase

Phase 2

Contacts

Heikki Minn, Professor (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02002455

Drug / Compound

Fluciclovine

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Language spoken: Finnish or Swedish
  • Mental status: Patients must be able to understand the meaning of the study
  • No previous surgical, radiation or endocrine treatment for prostate carcinoma
  • Diagnosis: Histologically confirmed adenocarcinoma of prostate
  • Patient agrees to undergo either surgery or external radiotherapy
  • Clinical stage T1c-T3aN0 based on transrectal ultrasound
  • Adequate histological sampling consisting of at least 3 biopsy samples from each lobe
  • Serum creatinine ≤ 1,5 x upper limit of normal (ULN)

Exclusion

  • Patient preference for active surveillance as a method of prostate cancer management
  • Infections: Patient must not have an uncontrolled serious infection
  • Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
  • No contraindications for MRI (cardiac pacemaker, intracranial clips etc)