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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT).
The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.
Clinical features and outcomes of the patients included in the study will be assessed as better detailed in the following lines:
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| Measure | Description | Time Frame |
|---|---|---|
| Practice of pelvic irradiation | Evaluate the number of patients treated with RT on pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer | Four months after the end of the enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Radiotherapy techniques used for prostate cancer irradiation | Analyze the number of patients treated with 3Dconformal Radiotherapy (3DCRT), Intensity Modulated Radiation Therapy (IMRT), Volumetric arch Therapy (VMAT), Tomotherapy, respectively with/without Image Guided Radiotherapy (IGRT) for pelvic irradiation | Four months after the end of the enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for prostate cancer without or after surgery, with or without association of hormonal treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Michela Buglione, Prof | University and Spedali Civili - Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University and Spedali Civili - Brescia | Brescia | 25123 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2016 | Nov 2, 2017 | Prot_SAP_000.pdf |
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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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| Outcome of treated prostate cancer | Biochemical relapse free survival | Three years after the end of the enrollment |
| Outcome of treated prostate cancer | Clinical relapse free survival | Three years after the end of the enrollment |
| Outcome of treated prostate cancer | Disease specific free survival | Three years after the end of the enrollment |
| Outcome of treated prostate cancer | Overall survival | Three years after the end of the enrollment |
| Toxicity of treated prostate cancer | register, using CTCAE v.4 acute and late urinary and rectal toxicities in the groups of patients treated with/without pelvic irradiation. | Within 6 months after the end of the treatment |
| Comparison of toxicity and outcome in the different groups | Using chi-square test compare toxicities and clinical outcome in the different groups of patients. | Three years after the end of the enrollment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |