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

Medical University of Graz

Status: Terminated

Conditions: Radiotherapy Side Effect; Prostate Cancer

Treatments: Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04535908

1091/2020

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 75+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Hypofractionated radiotherapy

Experimental group

Treatment:

Radiation: Hypofractionated radiotherapy