Hypofractionated Radiotherapy for Prostate Cancer
HRT20
1 other identifier
observational
300
1 country
1
Brief Summary
Radiotherapy is a standard definitive treatment for men with localized prostate cancer. Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects. This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2016
CompletedFirst Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2021
CompletedFebruary 10, 2023
February 1, 2023
5 years
February 19, 2019
February 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-related adverse events assessed by CTCAE v4.0
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
Participants should be followed continuously, for the duration of 10 years
Secondary Outcomes (1)
Biochemical relapse free survival
Participants should be followed continuously, for the duration of 10 years
Interventions
Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.
Eligibility Criteria
Patients with prostate cancer
You may qualify if:
- Histologic confirmation of adenocarcinoma of the prostate by biopsy
- Performance Status 0-2
- Signed informed consent form
You may not qualify if:
- Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- Anticoagulant treatment, individual assessment of antiplatelet therapy
- Previous pelvic radiotherapy
- Previous surgery for prostate cancer
- Previous transurethral resection of the prostate
- History of Crohn's Disease or Ulcerative Colitis
- Antecedents of rectal fistulas in the last 10 years
- Previous significant urinary obstructive symptoms
- Previous chemotherapeutic treatments
- Non-compliance with constraints established in this protocol (see special section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Terrassa
Terrassa, Barcelona, 08227, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NICOLAS FELTES
Consorci Sanitari de Terrassa
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 22, 2019
Study Start
October 5, 2016
Primary Completion
October 5, 2021
Study Completion
October 5, 2021
Last Updated
February 10, 2023
Record last verified: 2023-02