VMAT for Dominant Intraprostatic Lesion

Not Applicable

Completed

Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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).

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
IGRT/VMAT focal therapy boost to DIL	IGRT/VMAT focal therapy boost to DIL	Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biochemical Failure at 5 Years	5 years	Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
Acute and Late Rectal and Urinary Complications	5 years	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).
Local Control	6 and 9 months following radiotherapy	An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Free of Biochemical Progression	5 years	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.
Disease-free Survival (DFS)	5 years	Survival free of any event including biochemical failure, local failure, distant metastasis or death
Verification of Safety Margins	5 years	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
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	5 years	Assessment of the QoL perceived by the patient in the urinary incontinence, urinary abstraction irritation, bowel function, sexual function and vitality/hormone functions domains