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NCT Number: NCT02002455

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Turku University Hospital

Turku, 20521, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT, PET/MRI, mpMRI

Device

FACBC dose 370 megabecquerel (MBq)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Blue Earth Diagnostics
  • GE Healthcare

Registry information

Official study title

Preoperative Staging and Dose Escalated Radiotherapy of Prostate Carcinoma

Acronym: Flucipro

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2013
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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