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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04535908
• Other study ID #: 1091/2020
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: September 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Hypofractionated radiotherapy
Hypofractionated radiotherapy in prostate cancer patients

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute radiation - induced toxicity	Toxicity score using Common Terminology for Adverse Events (CTCAE)	Measurement at the last 1 day of radiotherapy
Primary	Acute radiation - induced toxicity	Toxicity score using Common Terminology for Adverse Events (CTCAE)	Measurement 3 months after completion of radiotherapy
Secondary	Overall survival	Analysis of survival	At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Secondary	Recurrence (biochemical)	Assessed by measurement of prostate specific antigen (PSA)	At 1, 2, 3 , 4, 5 years after completion of radiotherapy
Secondary	Recurrence (local)	Assessed by magnetic resonance imaging (MRI), positron emission tomography (optional)	At 1, 2, 3 , 4, 5 years after completion of radiotherapy