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

Overview

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.

Full Title of Study: “Clinical Study to Evaluate Hypofractionated Radiotherapy in Prostate Cancer Patients Aged 75 Years or Older.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 25, 2022

Interventions

  • Radiation: Hypofractionated radiotherapy
    • Hypofractionated radiotherapy in prostate cancer patients

Arms, Groups and Cohorts

  • Experimental: Hypofractionated radiotherapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Overall survival
    • Time Frame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
    • Analysis of survival
  • Recurrence (biochemical)
    • Time Frame: At 1, 2, 3 , 4, 5 years after completion of radiotherapy
    • Assessed by measurement of prostate specific antigen (PSA)
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Graz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tanja Langsenlehner, MD, Principal Investigator, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

References

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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