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OpenTrials
Completed

NCT Number: NCT03851926

Hypofractionated Radiotherapy for Prostate Cancer

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated volumetric radiotherapy in 20 fractions

Radiation

Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Official study title

Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions

Acronym: HRT20

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2019
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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