VMAT for Dominant Intraprostatic Lesion

NCT ID: NCT03030625

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2023-01-25

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGRT/VMAT focal therapy boost to DIL

Localized prostate cancer (PCa) of intermediate and high risk according to NCCN criteria

Group Type: OTHER

IGRT/VMAT focal therapy boost to DIL

Intervention Type: RADIATION

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

Interventions

IGRT/VMAT focal therapy boost to DIL

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario de la Princesa

Madrid, , Spain

Countries

Spain

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CaP-VMAT-DIL

Identifier Type: -

Identifier Source: org_study_id