VMAT for Dominant Intraprostatic Lesion

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa30 enrolled

Overview

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 (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

IGRT/VMAT focal therapy boost to DILRADIATION

Image-guided/VMAT 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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male \> 18 years old with histologic diagnostic of prostate adenocarcinoma * Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition) * PSA (prostate-specific antigen) \< 100 ng/ml * Gleason score 6-10 * Life expectancy \> 5 years * Patients who accept the radiotherapy treatment * Patients provided written informed consent before participating in the trial Exclusion Criteria: * Transurethral resection of the prostate or prior prostate surgery * Previous pelvic radiotherapy * Urethral stenosis with or without prior dilations * IPSS\>15 * Rectal diverticuli or rectal vascular malformations * Metastatic disease * Severe psychiatric or medical conditions that could hamper both treatment and follow-up

Locations (1)

Hospital Universitario de la Princesa

Madrid, Spain

Outcomes

Primary Outcomes

Number of Participants With Biochemical Failure at 5 Years

Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)

Time frame: 5 years

Local Control

An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.

Time frame: 6 and 9 months following radiotherapy

Acute and Late Rectal and Urinary Complications

Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).

Time frame: 5 years

Secondary Outcomes

Number of Participants Free of Biochemical Progression

Biochemical disease-free survival according to the Phoenix definition (PSA \>2 ng/mL above the currently observed PSA nadir. Defined as the time from enrollment to progression of biochemical disease, or death from any cause, or censoring at the date of the last contact.

Time frame: 5 years

Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score

Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains

Time frame: 5 years

Disease-free Survival (DFS)

Survival free of any event including biochemical failure, local failure, distant metastasis or death

Data from ClinicalTrials.gov

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