VMAT for Dominant Intraprostatic Lesion

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: IGRT/VMAT focal therapy boost to DIL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IGRT/VMAT focal therapy boost to DIL<br>Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria | Radiation: IGRT/VMAT focal therapy boost to DIL<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biochemical Failure at 5 Years | Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml) | 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. | 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). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 5 years | 
| Disease-free Survival (DFS) | Survival free of any event including biochemical failure, local failure, distant metastasis or death | 5 years | 
| Verification of Safety Margins | Quantification of the systematic and random errors during the preparation and administration of the radiotherapy treatment in 15 patients. Security margins estimation according to Van Herk formula | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VMAT, Prostate Cancer, Dominant Intraprostatic Lesion, Intensity modulated radiotherapy