Clinical trial NCT03030625: VMAT for Dominant Intraprostatic Lesion
Official title: Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
VMAT
Dominant Intraprostatic Lesion
Intensity modulated radiotherapy
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Biochemical Failure at 5 Years
timeFrame: 5 years
measure: Local Control
timeFrame: 6 and 9 months following radiotherapy
measure: Acute and Late Rectal and Urinary Complications
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants Free of Biochemical Progression
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Disease-free Survival (DFS)
timeFrame: 5 years
measure: Verification of Safety Margins
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
Study officials:
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