Clinical trial NCT04535908: Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Official title: Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Keywords: Hypofractionated radiotherapy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 23
Sex: MALE
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute radiation - induced toxicity
timeFrame: Measurement at the last 1 day of radiotherapy
measure: Acute radiation - induced toxicity
timeFrame: Measurement 3 months after completion of radiotherapy
Secondary outcomes:
measure: Overall survival
timeFrame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
measure: Recurrence (biochemical)
timeFrame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
measure: Recurrence (local)
timeFrame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
name: Tanja Langsenlehner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.