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 of protocol
Not provided at time of registration
Contact information
Dr L Incrocci
Scientific
Scientific
Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391421 |
|---|---|
| l.incrocci@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study |
| Study acronym | HYPRO |
| Study objectives | 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(s) | Medical Ethics Committee of Erasmus MC, The Netherlands, 13/06/2006, ref: MEC-2006-045 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2006 |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 800 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3008 AE
Netherlands
3008 AE
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Daniel den Hoed Kliniek
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
| Phone | +31 (0)10 4391421 |
|---|---|
| l.incrocci@erasmusmc.nl | |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Research organisation
KWF Kankerbestrijding
Private sector organisation / Other non-profit organizations
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 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 | 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.
