Prostate Cancer Clinical Trial
Official title:
Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Verified date | September 2022 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | May 25, 2022 |
Est. primary completion date | May 25, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 75 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
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. Erratum in: Lancet Oncol. 2016 Aug;17 (8):e321. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute radiation - induced toxicity | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement at the last 1 day of radiotherapy | |
Primary | Acute radiation - induced toxicity | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement 3 months after completion of radiotherapy | |
Secondary | Overall survival | Analysis of survival | At 1, 2, 3 , 4, 5 years after completion of radiotherapy | |
Secondary | Recurrence (biochemical) | Assessed by measurement of prostate specific antigen (PSA) | At 1, 2, 3 , 4, 5 years after completion of radiotherapy | |
Secondary | Recurrence (local) | Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional) | At 1, 2, 3 , 4, 5 years after completion of radiotherapy |
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