Hypofractionated Radiotherapy for Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03851926
• Lead Sponsor: Consorci Sanitari de Terrassa

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

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 Timeline

• Study Start: 2016-10-05
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Primary Completion: 2021-10-05
• Study Completion: 2021-10-05
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-related adverse events assessed by CTCAE v4.0	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 Outcome Measures

Name	Time	Method
Biochemical relapse free survival	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

Trial Locations

Locations (1)

Hospital de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain