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

• Register: ISRCTN
• Last refreshed on: 3 March 2020
• Main ID: ISRCTN85138529
• Date of registration: 22/11/2006
• Prospective Registration: Yes
• Primary sponsor: Erasmus Medical Center (The Netherlands)
• Public title: HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
• Scientific title: HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
• Date of first enrolment: 01/12/2006
• Target sample size: 800
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN85138529
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Phase III

Countries of recruitment

Netherlands

Contacts

• Name: L Incrocci

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate cancer
Cancer
Prostate cancer

Intervention(s)

Hypofractionation arm:
Total dose of 64.6 Gy in 19 fractions of 3.4 Gy, three times per week, in 7 weeks, using conformal External Beam Radiation Therapy (EBRT).

Reference arm:
78 Gy total dose consisting of 39 fractions of 2 Gy, five times per week, in 8 weeks, using conformal EBRT.

Primary Outcome(s)

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.

Other endpoints of this study will be:
1. The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC Late Radiation Morbidity Scale questionnaire and scoring system.
2. The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC Late Radiation Morbidity Scale questionnaire and scoring system.

Secondary Outcome(s)

1. Quality of life by using the EORTC-PR25 prostate module
2. Erectile functioning by using the International Index of Erectile Function (IIEF)

Secondary ID(s)

CKTO 2006-08

Source(s) of Monetary Support

KWF Kankerbestrijding

Ethics review

Status:
Approval date:
Contact:

Medical Ethics Committee of Erasmus MC, The Netherlands, 13/06/2006, ref: MEC-2006-045

Results

• Results available: Yes
• Date Completed: 01/12/2011