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.
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.
Study Type
OBSERVATIONAL
Enrollment
130
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.
Hospital Sírio-Libanes
Brasília, Federal District, Brazil
RECRUITINGHospital Sírio-Libanes
São Paulo, São Paulo, Brazil
RECRUITINGOverall Acute Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Time frame: During and up to 90 days after treatment ends (acute event)
Overall Acute Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5
Time frame: During and up to 90 days after treatment ends (acute event)
Overall Late Gastrointestinal Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Time frame: After 90 days up to 24 months from treatment (late event)
Overall Late Genitourinary Toxicity - According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 - toxicity will be graduated in a scale from 0 - 5.
Time frame: After 90 days up to 24 months from treatment (late event)
Freedom from biochemical failure survival
Prostate-Specific Antigen (PSA) values
Time frame: 12 and 24 months
Overall Survival
Defined as the percentage of participant on treatment group who are alive at 12 and 24 months after the start of treatment.
Time frame: 12 and 24 months
Cause specific Survival
Defined as the cancer survival in the absence of other causes of death at 12 and 24 months after the start of treatment.
Time frame: 12 and 24 months
Quality of life
The Expanded Prostate Cancer Index Composite (EPIC) - Brazilian Portuguese version. will be applied to assess urinary, bowel and sexual functions.
Time frame: 12 and 24 months
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