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
Principal Investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Kontakt
Kontakt:
Phone: 0043 316 385 87869
E-Mail: tanja.langsenlehner@medunigraz.at» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Medical University of Graz
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Tanja Langsenlehner, MD» Ansprechpartner anzeigen
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Tanja Langsenlehner, MD» Ansprechpartner anzeigen
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