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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04535908

Studienbeginn:
September 2020

Letztes Update:
13.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Senioren (66+)

Phase:
-

Sponsor:
Medical University of Graz

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations (1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Acute radiation - induced toxicity (Time Frame - Measurement at the last 1 day of radiotherapy):
Toxicity score using Common Terminology for Adverse Events (CTCAE)

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

Secondary outcome:

1. Overall survival (Time Frame - At 1, 2, 3 , 4, 5 years after completion of radiotherapy):
Analysis of survival

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

3. 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)

Geprüfte Regime

  • Hypofractionated radiotherapy:
    Hypofractionated radiotherapy in prostate cancer patients

Quelle: ClinicalTrials.gov


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