HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study

Phase 3

Completed

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN85138529
• Lead Sponsor: Erasmus Medical Center (The Netherlands)

Brief Summary

2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25656287 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27339116 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31593756 (added 14/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-22
• Study Completion: 2011-12-01
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 800

Inclusion Criteria

1. Histologically proven adenocarcinoma of the prostate
2. Intermediate or high risk prostate cancer:
2.1. Low risk:T1-2a and Prostate Specific Antigen [PSA] less than 10 µg/L and Gleason score less than or equal to six
2.2. Intermediate risk: Not low risk or high risk
2.3. High risk: One or more of the following high risk factors: T3-4, PSA more than 20 µg/L, Gleason score more than or equal to eight)
3. The administration of concomitant hormonal therapy is allowed
4. World Health Organisation (WHO) performance status zero to two
5. Written informed consent
6. Willing to fill out the quality of life questionnaires

Exclusion Criteria

1. Pretreatment PSA more than or equal to 60 µg/l
2. Previous irradiation in the pelvic region or radical prostatectomy
3. Radiological evidence of pelvic nodal disease (computed tomography [CT] pelvis)
4. Presence of distant metastasis (bone scintigraphy)
5. Patients candidates for elective lymph node irradiation
6. Low-risk prostate cancer (T1-2a and PSA less than 10 µg/L and Gleason score less than or equal to six)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Five-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> 1. The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC Late Radiation Morbidity Scale questionnaire and scoring system.<br> 2. The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC Late Radiation Morbidity Scale questionnaire and scoring system.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Quality of life by using the EORTC-PR25 prostate module<br> 2. Erectile functioning by using the International Index of Erectile Function (IIEF)<br>