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CompletedNCT03851926HRT20Updated Feb 10, 2023

Hypofractionated Radiotherapy for Prostate Cancer

An observational study in Prostate Cancer, sponsored by Consorci Sanitari de Terrassa. Completed at 1 site in Spain. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Consorci Sanitari de Terrassa · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Male
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Study 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

Read the 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.

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Conditions studied

  • Prostate Cancer

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Keywords

  • HYPOFRACTIONED
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 300 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with prostate cancer

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • RadiationHypofractionated volumetric radiotherapy in 20 fractions

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

06

What researchers measure

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

    Time frame: Participants should be followed continuously, for the duration of 10 years

Secondary outcomes

  1. Biochemical relapse free survival

    By Phoenix definition ( Nadir + 2 ng/ml) Participants should be followed at baseline and follow-up, for the duration of 10 years

    Time frame: Participants should be followed continuously, for the duration of 10 years

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Study locations

1 site
  • Hospital de Terrassa
    Terrassa, Barcelona 08227, Spain
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03851926
Lead sponsor
Consorci Sanitari de Terrassa
Responsible party
Nicolas Feltes (Principal Investigator, Consorci Sanitari de Terrassa) — Principal investigator
First posted
Feb 22, 2019
Start date
Oct 5, 2016
Primary completion
Oct 5, 2021
Completion
Oct 5, 2021
Last update
Feb 10, 2023

Study contacts

NICOLAS FELTES
study director · Consorci Sanitari de Terrassa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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