Hypofractionated Radiotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

— HRT20  

Official title:

Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851926
• Other study ID #: ONCORTCST2019-1
• Status: Completed
• Start date: October 5, 2016
• Est. completion date: October 5, 2021

Study information

• Verified date: February 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated volumetric radiotherapy in 20 fractions
Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.

Locations

Country	Name	City	State
Spain	Hospital de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Participants should be followed continuously, for the duration of 10 years