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

Not Applicable

Terminated

• Conditions: Radiotherapy Side Effect; Prostate Cancer
• Interventions: Radiation: Hypofractionated radiotherapy

• Registration Number: NCT04535908
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-02
• Study Start: 2020-09-16
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated radiotherapy	Hypofractionated radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Acute radiation - induced toxicity	Measurement 3 months after completion of radiotherapy	Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria