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

ISRCTN ISRCTN85138529
DOI https://doi.org/10.1186/ISRCTN85138529
Secondary identifying numbers CKTO 2006-08
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

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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleHYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
Study acronymHYPRO
Study hypothesisThe 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
ConditionProstate cancer
InterventionHypofractionation 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 typeOther
Primary outcome measureFive-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 measures1. Quality of life by using the EORTC-PR25 prostate module
2. Erectile functioning by using the International Index of Erectile Function (IIEF)
Overall study start date01/12/2006
Overall study end date01/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants800
Participant inclusion criteria1. 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 exclusion criteria1. 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 date01/12/2006
Recruitment end date01/12/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

Daniel den Hoed Kliniek
P.O. Box 5201
Rotterdam
3008 AE
Netherlands

Phone +31 (0)10 4391421
Email l.incrocci@erasmusmc.nl
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

KWF Kankerbestrijding
Private sector organisation / Other non-profit organizations
Alternative name(s)
The Dutch Cancer Society, Koningin Wilhelmina Fonds, DCS, KWF
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
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

Editorial Notes

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