Hypofractionated Radiotherapy for Prostate Cancer (HRT20)

February 8, 2023 updated by: Nicolas Feltes, Consorci Sanitari de Terrassa

Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed.

It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Hospital de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with prostate cancer

Description

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate by biopsy
  • Performance Status 0-2
  • Signed informed consent form

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related adverse events assessed by CTCAE v4.0
Time Frame: Participants should be followed continuously, for the duration of 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical relapse free survival
Time Frame: Participants should be followed continuously, for the duration of 10 years
By Phoenix definition ( Nadir + 2 ng/ml) Participants should be followed at baseline and follow-up, for the duration of 10 years
Participants should be followed continuously, for the duration of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2016

Primary Completion (ACTUAL)

October 5, 2021

Study Completion (ACTUAL)

October 5, 2021

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (ACTUAL)

February 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONCORTCST2019-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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