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

Primary Purpose

Prostate Cancer, Radiotherapy Side Effect

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hypofractionated radiotherapy
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hypofractionated radiotherapy

Eligibility Criteria

75 Years - undefined (Older Adult)MaleDoes not accept 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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Acute radiation - induced toxicity
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Acute radiation - induced toxicity
Toxicity score using Common Terminology for Adverse Events (CTCAE)

Secondary Outcome Measures

Overall survival
Analysis of survival
Recurrence (biochemical)
Assessed by measurement of prostate specific antigen (PSA)
Recurrence (local)
Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional)

Full Information

First Posted
August 25, 2020
Last Updated
September 29, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04535908
Brief Title
Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Official Title
Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Treatment standard has changed.
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Radiotherapy Side Effect
Keywords
Hypofractionated radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiotherapy
Intervention Description
Hypofractionated radiotherapy in prostate cancer patients
Primary Outcome Measure Information:
Title
Acute radiation - induced toxicity
Description
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Time Frame
Measurement at the last 1 day of radiotherapy
Title
Acute radiation - induced toxicity
Description
Toxicity score using Common Terminology for Adverse Events (CTCAE)
Time Frame
Measurement 3 months after completion of radiotherapy
Secondary Outcome Measure Information:
Title
Overall survival
Description
Analysis of survival
Time Frame
At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Title
Recurrence (biochemical)
Description
Assessed by measurement of prostate specific antigen (PSA)
Time Frame
At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Title
Recurrence (local)
Description
Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional)
Time Frame
At 1, 2, 3 , 4, 5 years after completion of radiotherapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Langsenlehner, MD
Organizational Affiliation
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27339115
Citation
Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20. Erratum In: Lancet Oncol. 2016 Aug;17 (8):e321.
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Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.

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