Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Anders Widmark


Contact details

Department of Oncology
Umeå University Hospital
SE-901 85

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Hypofractionated radiotherapy of intermediate risk localised prostate cancer: a phase III, randomised, open, multicentre trial



Study hypothesis

To demonstrate a 10% unit increase (70% to 80%) in freedom from failure (prostate specific antigen [PSA] or any clinical test) in the HYPO-RT arm at 5 years after the end of treatment.

Ethics approval

Local medical ethics committee (Regionala etikprövningsnämnden i Umeå) gave approval on the 9th December 2003 (ref: 03-513)

Study design

Phase III randomised open multicentre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Can be found at (Swedish only) under PDF-dokument/Kliniska studier: HYPO-RT-PC


Intermediate risk localised prostate cancer


Treatment technique:
The radiation treatment shall be given with external photon beam therapy with three-dimensional conformal radiotherapy (3D-CRT) and/or intensity modulated radiation therapy (IMRT) techniques. It is left to each centre to decide upon the optimal technique (number of beams, beam weights, beam angles, beam shaping, etc). The same treatment technique shall be used in both trial arms within the centre. The position of the prostate shall be verified prior to every fraction with electronic kV or MV portal imaging or x-ray volumetric imaging (cone beam CT) using implanted markers. The treatment should start as soon as readily possible after the verification/correction. The monitor units (dose) used for verification of position should be considered and compensated for if MV portal imaging is used. Each centre should have treated at least two patients with their specific marker and image guidance technique before entering the study.

Fractionation schedule and treatment durations:
Conventional arm: radiotherapy is given daily (5 days/week) with 39 fractions of 2.0 Gy, i.e. total 78.0 Gy. The total treatment time is 53 - 55 days. Maximum allowed treatment days are 65.
Hypofractionated arm: radiotherapy is given working-days with 7 fractions of 6.1 Gy, i.e. total 42.7 Gy. The total treatment time is 15 - 19 days. Treatment is given every other weekday, always including two weekends.

Clinical follow up:
Patients should be seen by a doctor (urologist/surgeon or oncologist) for clinical evaluation every 3 months (+ 14 days) preferentially by an oncologist for the first year, and every six months (+ 28 days) thereafter until metastases are verified. Thereafter patients should be followed for verification of death.

Intervention type



Phase III

Drug names

Primary outcome measures

Freedom from failure (PSA or any clinical), measured five years after the end of treatment.

Secondary outcome measures

1. PSA response rate
2. Time to symptoms related to local progression
3. Time to symptoms related to distant progression
4. Cancer specific survival
5. Overall survival
6. Quality of Life (QoL) and side effects with special focus on sexual function, urinary and gastrointestinal morbidity

Measured five years after the end of treatment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Men less than 75 years of age and, as judged by the doctor, a life expectancy of 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) grades 0 - 2
2. Patients with a histologically verified prostatic cancer
3. Patients with intermediate risk prostatic cancer of clinical category T1c - T3a with one or two of the following risk factors:
3.1. T3a or Gleason greater than 7
3.2. PSA greater than 10 according to the TNM classification system UICC 2002
4. PSA less than 20 µg/L
5. The patients should have no evidence of metastases according to the definition above
6. Patients should be lymph node negative according to the definition above, i.e. staging
7. Patients should be suitable for radiotherapy
8. Patients must have signed informed consent

Participant type


Age group




Target number of participants

In total: 592

Participant exclusion criteria

1. Patients who earlier have undergone any other treatment for prostatic cancer
2. Patients unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis)
3. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
4. Previous hormone therapy (castration or anti-androgens)
5. Any condition that prevent markers implantation, i.e. anal fissure

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Oncology
SE-901 85

Sponsor information


County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)

Sponsor details

901 89

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

Nordic Cancer Union (Nordiska Cancerunionens [NCU]) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes