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

September 29, 2022 updated by: Medical University of Graz

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated radiotherapy
Radiation: Hypofractionated radiotherapy
Hypofractionated radiotherapy in prostate cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute radiation - induced toxicity
Time Frame: Measurement at the last 1 day of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measurement at the last 1 day of radiotherapy
Acute radiation - induced toxicity
Time Frame: Measurement 3 months after completion of radiotherapy
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Measurement 3 months after completion of radiotherapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Tanja Langsenlehner, MD, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Actual)

May 25, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1091/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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