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

NCT ID: NCT04535908

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2022-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Radiotherapy Side Effect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionated radiotherapy

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

Hypofractionated radiotherapy in prostate cancer patients

Interventions

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Hypofractionated radiotherapy

Hypofractionated radiotherapy in prostate cancer patients

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanja Langsenlehner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 27339115 (View on PubMed)

Other Identifiers

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1091/2020

Identifier Type: -

Identifier Source: org_study_id

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