Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title: Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer: a Prospective Cohort.

Status Recruiting

Clinical Trial Summary

Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:

1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or

2. Improving tumour control, mainly freedom from biochemical failure survival.

Clinical Trial Description

The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.

Primary Outcome Measures:

1. Acute and late radiation induced toxicities.

Secondary Outcome Measures:

1. Freedom from prostate cancer recurrence - freedom from biochemical failure survival;

2. Cause specific and overall survival

3. Aspects of quality of life and health economics

Study Design:

Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment

Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Study Population:

Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer. ;

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT02651896
• Study type: Observational
• Source: Hospital Sirio-Libanes
• Contact: Rafael Gadia, MD
• Phone: +556130447212
• Email: rafaelgadia@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2015
• Completion date: December 2019