Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Study Overview
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Brief Summary
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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: Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or Improving tumour control, mainly freedom from biochemical failure survival.

Detailed Description
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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: Freedom from prostate cancer recurrence - freedom from biochemical failure survival; Cause specific and overall survival 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.

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

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Radiation: HypoIGRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate Patients older than 18 years old Patients who accept to perform follow up in the radiation oncology department Performance Status ≥ 70 Written informed consent Exclusion Criteria: Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HypoIGRT<br>Low Risk (T1-T2a, Gleason score 6, and PSA < 10 ng/mL) Intermediate Risk (T1-T2c, Gleason 7, and PSA 10-20 ng/mL) High Risk (T3 - 4 , Gleason 8-10, and/or PSA > 20 ng/mL) Neoadjuvant hormone therapy is allowed on groups 2 and 3 | Radiation: HypoIGRT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall 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 | 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 | 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. | 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. | After 90 days up to 24 months from treatment (late event) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from biochemical failure survival | Prostate-Specific Antigen (PSA) values | 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. | 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. | 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. | 12 and 24 months |