HYpofractionated irradiation for PROstate cancerA randomized multicenter phase III study.

• Conditions: Prostate cancer has become the most common non-skin malignancy in men in Western countries. Over recent years the number of diagnosed patients has increased dramatically because of routine prostate-specific antigen (PSA) testing. For a large proportion of prostate cancer patients, external-beam radiotherapy (EBRT) will be the treatment of choice.

• Registration Number: NL-OMON22744
• Lead Sponsor: Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam, Netherlands Cancer Institute, Amsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

1. Histologically proven adenocarcinoma of
the prostate

Exclusion Criteria

1. Pretreatment PSA >/= 60 µg/l

2. Previous irradiation in the pelvic region or radical prostatectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year relapse free survival after treatment. Relapse is defined as biochemical relapse, clinical relapse, loco-regional or distant relapse or start with hormonal therapy, whichever occurs first. Biochemical relapse will be defined in this study as PSA greater than the current nadir plus 2 mg/l, without backdating. <br /><br>Other endpoints of this study will be:<br /><br>The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. <br /><br>The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. <br>

Secondary Outcome Measures

Name	Time	Method
Quality of life by using the EORTC-PR25 prostate module, and erectile functioning by using the International Index of Erectile Function (IIEF).