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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04535908
Other study ID # 1091/2020
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date May 25, 2022

Study information

Verified date September 2022
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Radiation:
Hypofractionated radiotherapy
Hypofractionated radiotherapy in prostate cancer patients

Locations

Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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

Outcome

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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