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

M

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)

23 participants in 1 patient group

Hypofractionated radiotherapy
Experimental group
Treatment:
Radiation: Hypofractionated radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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