Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

Study Overview
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Brief Summary
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The majority of all new prostate cancer cases are diagnosed in men aged > 70 years, with the highest incidence in men aged > 90 years. Management options for localized prostate cancer include active surveillance in patients with low-risk disease, radical prostatectomy or external beam radiation therapy. In previous studies, hypofractionated prostate cancer irradiation regimens have been shown to represent a highly effective treatment option for prostate cancer. However, patients aged 75 years or older were underrepresented in most trials resulting in the lack of a robust evidence base. The proposed study will evaluate radiation-induced toxicity as well as outcome after hypofractionated external beam radiotherapy in prostate cancer patients aged 75 years or older.

Official Title
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Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

Conditions
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Prostate Cancer, Radiotherapy Side Effect

Intervention / Treatment
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* Radiation: Hypofractionated radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed prostate cancer adenocarcinoma definitive radiotherapy for curative intent low or intermediate risk prostate cancer patient age ≥ 75 years given informed consent Exclusion Criteria: chronic inflammatory bowel disease high risk prostate cancer lymph node or distant metastases unable to give informed consent

Ages Eligible for Study
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Minimum Age: 75 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiotherapy<br> | Radiation: Hypofractionated radiotherapy<br>* Hypofractionated radiotherapy in prostate cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute radiation - induced toxicity | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement at the last 1 day of radiotherapy | 
| Acute radiation - induced toxicity | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement 3 months after completion of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Analysis of survival | At 1, 2, 3 , 4, 5 years after completion of radiotherapy | 
| Recurrence (biochemical) | Assessed by measurement of prostate specific antigen (PSA) | At 1, 2, 3 , 4, 5 years after completion of radiotherapy | 
| Recurrence (local) | Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional) | At 1, 2, 3 , 4, 5 years after completion of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionated radiotherapy