Contact information
Type
Scientific
Primary contact
Dr L Incrocci
ORCID ID
Contact details
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391421
l.incrocci@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CKTO 2006-08
Study information
Scientific title
HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
Acronym
HYPRO
Study hypothesis
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
Medical Ethics Committee of Erasmus MC, The Netherlands, 13/06/2006, ref: MEC-2006-045
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measures
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 measures
1. Quality of life by using the EORTC-PR25 prostate module
2. Erectile functioning by using the International Index of Erectile Function (IIEF)
Overall trial start date
01/12/2006
Overall trial end date
01/12/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
800
Participant 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)
Recruitment start date
01/12/2006
Recruitment end date
01/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
Sponsor information
Organisation
Erasmus Medical Center (The Netherlands)
Sponsor details
Daniel den Hoed Kliniek
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391421
l.incrocci@erasmusmc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
KWF Kankerbestrijding
Alternative name(s)
Dutch Cancer Society
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25656287
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27339116