VMAT for Dominant Intraprostatic Lesion (CaP-VMAT-DIL)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: IGRT/VMAT focal therapy boost to DIL

Study type: Interventional

Funder types: Other

Identifiers

NCT03030625

CaP-VMAT-DIL

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

IGRT/VMAT focal therapy boost to DIL

Other group

Description:

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

Treatment:

Radiation: IGRT/VMAT focal therapy boost to DIL