Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer
Phase: NA
Conditions: Prostate Cancer
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

CaP-VMAT-DIL 
 
18th November 2020 
NCT03030625 
 
Version 8 
Página 1 de 2 
 
TITLE:  
Dose Intensification with a Focal Boost to Dominant Intraprostatic Lesion using 
Volumetric Modulated ArcTherapy /Image Guided Radiotherapy in Patients with 
Localized Prostate Cancer 
 
ClinicalTrials.gov Identifier: NCT03030625 
Version: 8, 18th November 2020 
 
 
ABSTRACT: 
Prostate cancer is a multi-focal disease and conventional therapies address this by 
treating the whole gland. However, numerous evidence coming from prostate 
pathology studies suggest the existence of a dominant cancer focus or dominant lesion 
(DL) within the gland that may be the nucleus of the aggressiveness of the cancer and 
therefore of recurrence post treatment. Thus strategies to identify and intensify 
treatment to this DL are under active investigation. Advances in multiparametric 
magnetic resonance imaging (mpMRI) have shown promising results in identifying focal 
lesions and advances in high accuracy radiotherapy have enabled dose intensification. 
 
Hypothesis 
The hypothesis is that differential boosting with focal dose escalation delivered by VMAT 
to an imaging (mpMPR) defined DL within the prostate is associated with a higher PSA, 
clinical (mpMRI) and histological control without a significant increase in toxicity (both 
acute and late) in males with localized prostate. 
 
Objectives 
The aim of this study was to determine the efficacy and safety of the implementation of 
a program of " image-guided focal Intensification dose to intraprostatic dominant lesion 
" in men with localized prostate cancer (PCa) of intermediate and high risk (criteria 
NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP 
within the established dose escalation protocol with intensity modulated image-guided 
radiotherapy (IMRT / IGRT). 
 
Primary objectives: 
- To increase biochemical and local control of patients localized PCa of intermediate and 
high- risk. 
- To maintain or decrease the incidence of acute and late urinary rectal complications 
despite increased dose (focal) radiotherapy. 
 
Secondary objectives: 
- Biochemical disease-free survival at 3 yrs (according to RTOG‐ASTRO Phoenix 
Consensus Conference criteria). 
- Assessment of the quality of life perceived by the patient in the urinary, digestive and 
hormone domains. 
- To determine the impact of treatment on the disease-free survival (DFS). 

CaP-VMAT-DIL 
 
18th November 2020 
NCT03030625 
 
Version 8 
Página 2 de 2 
 
- To assess the adequacy of the safety margins of the treatment volume and the 
possibility of reducing these margins to minimize the risk of complications when 
incorporating specific immobilization. 
 
SAMPLE SIZE 37 PATIENTS 
 
STUDY VARIABLES DEFINITION 
1. Patients were counted as biochemical failures according to the Phoenix definition 
(PSA >2 ng/mL above the currently observed PSA nadir). The Kaplan- Meier method 
was used to estimate the probability of biochemical control and of DFS. 
2. Biochemical relapse-free survival (bRFS) was calculated from the time of first 
radiation treatment to failure, last follow-up or death. PSA nadir was set to be the 
lowest PSA value following treatment completion. Benign bounce was defined as 
nadir +0.2 ng/ml as long as subsequent PSAs after the bounce dropped lower than 
the relative nadir before the bounce. 
3. Morphological and functional response was evaluated by mpMRI at 12 months after 
radiotherapy and compared to the baseline scans. 
4. Acute toxicity was assessed in terms of the incidence and severity of genitourinary 
(GU) and gastrointestinal (GI) adverse events from 48 h until 3 months after the 
procedure. 
5. Late toxicity defined as the maximal toxicity per patient more than 90 days after 
completion of RT Late adverse effects of radiation assessed at each follow-up visit 
using the radiation morbidity scoring criteria of the European Organization for 
Research and Treatment of Cancer Radiation Therapy Oncology Group 
(EORTC/RTOG) and The Common Terminology Criteria for specific Adverse Events. 
 
The incidence of late adverse effects was calculated as the occurrence of the maximum 
grade toxicity per patient divided by the number of patients in each arm. The c2 or Fisher 
exact test was used to evaluate differences in patient and treatment characteristics for 
categorical variables. The t test, analysis of variance, or Mann-Whitney test was used, 
depending on the type and distribution of the variables, to evaluate differences in 
patient and treatment characteristics for continuous data. The cumulative incidence 
method was used to estimate time to late toxicity, and treatment groups were 
compared using the log-rank test. Death from any cause was considered a competing 
risk.