HYpofractionated irradiation for PROstate cancer A randomized multicenter phase III study.

Hypofractionated irradiation for Prostate cancer. Improving 5-year relapse free survival without increasing toxicity.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22744

Enrollment

800

Registered

2006-08-30

Start date

2006-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer has become the most common non-skin malignancy in men in Western countries. Over recent years the number of diagnosed patients has increased dramatically because of routine prostate-specific antigen (PSA) testing. For a large proportion of prostate cancer patients, external-beam radiotherapy (EBRT) will be the treatment of choice.

Interventions

hypofractionation arm: total dose of 64.6 Gy in 19 fractions of 3.4 Gy, 3 times/week, in 7 weeks, using conformal EBRT reference arm: 78 Gy total dose consisting of 39 fractions of 2 Gy, 5 times/week,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of the prostate 2. Intermediate or high risk prostate cancer (Low risk: T1-2a and PSA 20 µg/L, Gleason score >/= 8) 3. The administration of concomitant hormonal therapy is allowed 4. WHO performance status 0-2 5. Written informed consent 6. Willing to fill out the quality of life questionnaires.

Exclusion criteria

Exclusion criteria: 1. Pretreatment PSA >/= 60 µg/l 2. Previous irradiation in the pelvic region or radical prostatectomy 3. Radiological evidence of pelvic nodal disease (CT pelvis) 4. Presence of distant metastasis (Bone scintigraphy) 5. Patients candidates for elective lymphnode irradiation 6. Low risk prostate cancer. (T1-2a and PSA < 10 µg/L and Gleason score </= 6)

Design outcomes

Primary

Measure	Time frame
5-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: The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system.	—

Measure

Time frame

5-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: The acute gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system. The late gastro-intestinal and genito-urinary toxicities by using the RTOG/EORTC questionnaire and scoring system.

—

Secondary

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

Contacts

Public ContactL. Incrocci

Erasmus Medical Center, Daniel den Hoed Cancer Center, P.O. Box 5201

l.incrocci@erasmusmc.nl+31 (0)10 4391421

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)