Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04535908

Enrollment

Registered

2020-09-02

Start date

2020-09-16

Completion date

2022-05-25

Last updated

2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Radiotherapy Side Effect

Keywords

Hypofractionated radiotherapy

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.

Interventions

RADIATIONHypofractionated radiotherapy

Hypofractionated radiotherapy in prostate cancer patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

75 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Acute radiation - induced toxicity	Measurement at the last 1 day of radiotherapy	Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary

Measure	Time frame	Description
Overall survival	At 1, 2, 3 , 4, 5 years after completion of radiotherapy	Analysis of survival
Recurrence (biochemical)	At 1, 2, 3 , 4, 5 years after completion of radiotherapy	Assessed by measurement of prostate specific antigen (PSA)
Recurrence (local)	At 1, 2, 3 , 4, 5 years after completion of radiotherapy	Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026