NCT04535908

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

August 25, 2020

Last Update Submit

September 29, 2022

Conditions

Prostate CancerRadiotherapy Side Effect

Keywords

Hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (2)

  • Acute radiation - induced toxicity

    Toxicity score using Common Terminology for Adverse Events (CTCAE)

    Measurement at the last 1 day of radiotherapy

  • Acute radiation - induced toxicity

    Toxicity score using Common Terminology for Adverse Events (CTCAE)

    Measurement 3 months after completion of radiotherapy

Secondary Outcomes (3)

  • Overall survival

    At 1, 2, 3 , 4, 5 years after completion of radiotherapy

  • Recurrence (biochemical)

    At 1, 2, 3 , 4, 5 years after completion of radiotherapy

  • Recurrence (local)

    At 1, 2, 3 , 4, 5 years after completion of radiotherapy

Study Arms (1)

Hypofractionated radiotherapy

EXPERIMENTAL
Radiation: Hypofractionated radiotherapy

Interventions

Hypofractionated radiotherapyRADIATION

Hypofractionated radiotherapy in prostate cancer patients

Hypofractionated radiotherapy

Eligibility Criteria

Age75 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • histologically confirmed prostate cancer adenocarcinoma
  • definitive radiotherapy for curative intent
  • low or intermediate risk prostate cancer
  • patient age ≥ 75 years
  • given informed consent

You may not qualify if:

  • chronic inflammatory bowel disease
  • high risk prostate cancer
  • lymph node or distant metastases
  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related 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.

    PMID: 27339115BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsRadiation Injuries

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Tanja Langsenlehner, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 2, 2020

Study Start

September 16, 2020

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)