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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated volumetric radiotherapy in 20 fractions | Radiation | Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| NICOLAS FELTES | Consorci Sanitari de Terrassa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Terrassa | Terrassa | Barcelona | 08227 | Spain |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |