Hypofractionated Radiotherapy for Prostate Cancer

Study Overview
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Brief Summary
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Radiotherapy is a standard definitive treatment for men with localized prostate cancer. Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects. This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0

Detailed Description
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Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Official Title
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Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated volumetric radiotherapy in 20 fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic confirmation of adenocarcinoma of the prostate by biopsy Performance Status 0-2 Signed informed consent form Exclusion Criteria: Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies Anticoagulant treatment, individual assessment of antiplatelet therapy Previous pelvic radiotherapy Previous surgery for prostate cancer Previous transurethral resection of the prostate History of Crohn's Disease or Ulcerative Colitis Antecedents of rectal fistulas in the last 10 years Previous significant urinary obstructive symptoms Previous chemotherapeutic treatments Non-compliance with constraints established in this protocol (see special section

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

| Intervention/Treatment |
| --- |
|Radiation: Hypofractionated volumetric radiotherapy in 20 fractions|Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-related adverse events assessed by CTCAE v4.0 | Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0 | Participants should be followed continuously, for the duration of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical relapse free survival | By Phoenix definition ( Nadir + 2 ng/ml) Participants should be followed at baseline and follow-up, for the duration of 10 years | Participants should be followed continuously, for the duration of 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HYPOFRACTIONED