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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated radiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | Hypofractionated radiotherapy in prostate cancer patients |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Langsenlehner, MD | Medical University of Graz, Dept. of Therapeutic Radiology and Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27339115 | Background | Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |