Phase III study of HYPOfractionated RadioTherapy of intermediate risk localised Prostate Cancer
| ISRCTN | ISRCTN45905321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45905321 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/12/2008
- Registration date
- 10/02/2009
- Last edited
- 15/01/2021
- 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
Prof Anders Widmark
Scientific
Scientific
Department of Oncology
Umeå University Hospital
Umeå
SE-901 85
Sweden
Study information
| Study design | Phase III randomised open multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.oc.umu.se/ (Swedish only) under PDF-dokument/Kliniska studier: HYPO-RT-PC |
| Scientific title | Hypofractionated radiotherapy of intermediate risk localised prostate cancer: a phase III, randomised, open, multicentre trial |
| Study acronym | HYPO-RT-PC |
| 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(s) | Local medical ethics committee (Regionala etikprövningsnämnden i Umeå) gave approval on the 9th December 2003 (ref: 03-513) |
| Condition | Intermediate risk localised prostate cancer |
| Intervention | 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 | Other |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Overall study end date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | In total: 592 |
| Total final enrolment | 1200 |
| 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 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 | 01/07/2005 |
| Recruitment end date | 30/06/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Oncology
Umeå
SE-901 85
Sweden
SE-901 85
Sweden
Sponsor information
County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)
Hospital/treatment centre
Hospital/treatment centre
-
Umeå
901 89
Sweden
| landstinget@vll.se | |
| Website | http://www.vll.se |
"ROR" |
https://ror.org/04xvhsp09 |
Funders
Funder type
Research organisation
Nordic Cancer Union (Nordiska Cancerunionens [NCU]) (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/08/2019 | 24/06/2019 | Yes | No |
| Results article | quality of life results | 01/02/2021 | 15/01/2021 | Yes | No |
Editorial Notes
15/01/2021: Publication reference added.
24/06/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the results publication.
