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This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT in 4 fraction | Experimental | Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Other | hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients. | Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded. | up to 5 years |
| Tumour response to local radiation therapy by assessing freedom from biochemical failure. | Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA). | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |