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This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Stereotactic radiotherapy with a total dose of 36.25 Gy in 5 fractions (7.25 Gy per fraction, 2 fractions per week) in low risk prostate cancer patients is delivered to evaluate acute and subacute toxicty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | during treatment and up to 3 month from RT end | up to 3 months |
| Late toxicity | since 4 month from RT end | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Time from treatment end to biochemical recurrence or loco-regional recurrence or metastatic disease | up to 5 year |
| Disease specific survival | Time from RT end to the date of patient death for cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU San Martino-IST | Genoa | GE | 16132 | Italy | ||
| AO Città della salute e della scienza - Molinette |
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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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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| up to 5 years |
| Overall survival | Time from RT end to the date of patient death for any cause | up to 5 years |
| Turin |
| TO |
| Italy |
| Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia | Brescia | Italy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |