HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study

Conditions

Prostate cancer Cancer Prostate cancer

Incrocci L, Wortel RC, Alemayehu WG, Aluwini S, Schimmel E, Krol S, van der Toorn PP, Jager H, Heemsbergen W, Heijmen B, Pos F.

2016-06-20345 citations

10.1016/s1470-2045(16)30070-5

Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): late toxicity results from a randomised, non-inferiority, phase 3 trial.

Aluwini S, Pos F, Schimmel E, Krol S, van der Toorn PP, de Jager H, Alemayehu WG, Heemsbergen W, Heijmen B, Incrocci L.

2016-03-09177 citations

10.1016/s1470-2045(15)00567-7

Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): acute toxicity results from a randomised non-inferiority phase 3 trial.

Aluwini S, Pos F, Schimmel E, van Lin E, Krol S, van der Toorn PP, de Jager H, Dirkx M, Alemayehu WG, Heijmen B, Incrocci L.

2015-02-03129 citations

10.1016/s1470-2045(14)70482-6

Interventions

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). Refer

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
1. Quality of life by using the EORTC-PR25 prostate module 2. Erectile functioning by using the International Index of Erectile Function (IIEF)	—

Countries

Netherlands

Outcome results

None listed