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HYpofractionated irradiation for PROstate cancer
A randomized multicenter phase III study.



- candidate number2224
- NTR NumberNTR759
- ISRCTNISRCTN85138529
- Date ISRCTN created22-nov-2006
- date ISRCTN requested8-nov-2006
- Date Registered NTR30-aug-2006
- Secondary IDsCKTO 2006-08 
- Public TitleHYpofractionated irradiation for PROstate cancer
A randomized multicenter phase III study.
- Scientific TitleHypofractionated irradiation for Prostate cancer.
Improving 5-year relapse free survival without increasing toxicity.
- 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.
- Healt Condition(s) or Problem(s) studiedProstate cancer
- Inclusion criteria1. Histologically proven adenocarcinoma of the prostate
2. Intermediate or high risk prostate cancer
(Low risk: T1-2a and PSA < 10 g/L and Gleason score Intermediate risk: Not low risk or high risk
High risk: One or more of the following high risk factors: T3-4, PSA > 20 g/L, Gleason score >/= 8)
3. The administration of concomitant hormonal therapy is allowed
4. WHO performance status 0-2
5. Written informed consent
6. Willing to fill out the quality of life questionnaires.
- Exclusion criteria1. Pretreatment PSA >/= 60 g/l
2. Previous irradiation in the pelvic region or radical prostatectomy
3. Radiological evidence of pelvic nodal disease (CT pelvis)
4. Presence of distant metastasis (Bone scintigraphy)
5. Patients candidates for elective lymphnode irradiation
6. Low risk prostate cancer. (T1-2a and PSA < 10 g/L and Gleason score
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2006
- planned closingdate1-dec-2011
- Target number of participants800
- Interventionshypofractionation arm: total dose of 64.6 Gy in 19 fractions of 3.4 Gy, 3 times/week, in 7 weeks, using conformal EBRT reference arm: 78 Gy total dose consisting of 39 fractions of 2 Gy, 5 times/week, in 8 weeks, using conformal EBRT
- Primary outcome5-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:
The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system.
The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system.
- Secondary outcomeQuality of life by using the EORTC-PR25 prostate module, and erectile functioning by using the International Index of Erectile Function (IIEF).
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. L. Incrocci
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L. Incrocci
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsN/A
- Brief summaryIn the last decade substantial improvements in the external-beam radiotherapy for prostate cancer have been made. Most attention has been focused on the introduction of new techniques and dose escalation has significantly increased treatment outcome. Less attention has been paid to fractionation. The disparity between / = 4 Gy for late complications and the values for prostate tumors (/ 2) raises the prospect that we might be able to further improve treatment outcome by treating prostate cancer with hypofractionation. Hypofractionated schedules for prostate cancer could lead to a high therapeutic gain as well as economic and logistic advantages. The study wants to demonstrate the superiority of the hypofractionated schedule with respect to the relapse rate. It will be a prospective, open, randomized phase III trial. Patients will be randomized to a total dose of 78 Gy in 39 daily fractions of 2 Gy, 5 times/week, in 8 weeks or to a total dose of 64.6 Gy in 19 fractions of 3.4 Gy, 3 times/week, in 7 weeks. End-points will be the 5-year relapse-free survival after treatment and the acute and late gastro-intestinal and genito-urinary toxicity. Secondary end-points: quality of life.
- Main changes (audit trail)
- RECORD30-aug-2006 - 4-dec-2006


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