NCT02651896

Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
RADIATION	HypoIGRT	Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups. For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description). Image guidance with cone beam CT will be mandatory before every treatment fraction.

Timeline

• Start date: 2015-12-20
• Primary completion: 2018-07-01
• Completion: 2019-12-01
• First posted: 2016-01-11
• Last updated: 2017-08-25

Locations

2 sites across 1 country: Brazil