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

ISRCTN	ISRCTN85138529
DOI	https://doi.org/10.1186/ISRCTN85138529
Protocol serial number	CKTO 2006-08
Sponsor	Erasmus Medical Center (The Netherlands)
Funder	KWF Kankerbestrijding

Submission date: 22/11/2006
Registration date: 22/11/2006
Last edited: 14/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr L Incrocci
Scientific

Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone	+31 (0)10 4391421
Email	l.incrocci@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
Study acronym	HYPRO
Study objectives	The hypofractionated regimen of 19 fractions will result in an increase of relapse-free survival by 10% with the same acute and late toxicity as the standard fractionation of 39 fractions.
Ethics approval(s)	Medical Ethics Committee of Erasmus MC, The Netherlands, 13/06/2006, ref: MEC-2006-045
Health condition(s) or problem(s) studied	Prostate cancer
Intervention	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.
Intervention type	Other
Primary outcome measure(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.
Key secondary outcome measure(s)	1. Quality of life by using the EORTC-PR25 prostate module 2. Erectile functioning by using the International Index of Erectile Function (IIEF)
Completion date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	800
Key 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
Key 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)
Date of first enrolment	01/12/2006
Date of final enrolment	01/12/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3008 AE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No
Results article	results	01/08/2016		Yes	No
Results article	results	01/01/2020	14/02/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2020: Publication reference added.
27/06/2016: Publication reference added.