Condition category
Cancer
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
27/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes

27/06/2016: Publication reference added.