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This study aims to probe the effect of SBRT as a treatment oligometastases of prostate cancer, regardless of basal treatment received, and I know the response, biochemical control, the progression-free survival as well as their impact on quality of life.
Primary Objective: Local and symptomatic oligometastases Control of prostate cancer treated by SBRT.
Secondary Objectives: Analyzing biochemical progression rates, progression-free survival, chemotherapy-free survival and overall survival. Analyze toxicities and quality of life of patients before and after treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT | Experimental | Stereotactic Body Radiation Therapy for Oligometastases (SBRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy for Oligometastases | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without disease progression of prostate cancer treated by SBRT | Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival measured with Kaplan-Meier method | the time to death will be defined as the time between the date when the patient is treated with SBRT and the date of death, or the last follow-up visit. | patients will be followed up an average of 5 years |
| Number of patients with an adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio J Conde Moreno, MD | Grupo de Investigación Clínica en Oncología Radioterapia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GICOR | Madrid | Las Rozas | 28290 | Spain | ||
| Hospital Puerta de Hierro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38944806 | Derived | Conde-Moreno AJ, Lopez-Campos F, Hervas A, Morillo V, Mendez A, Puertas MDM, Valero-Albarran J, Gomez Iturriaga A, Rico M, Vazquez ML, Samper Ots PM, Perez-Romasanta LA, Pastor J, Ibanez C, Ferrer F, Zapatero A, Garcia-Blanco AS, Rodriguez A, Ferrer C. A Phase II Trial of Stereotactic Body Radiation Therapy and Androgen Deprivation for Oligometastases in Prostate Cancer (SBRT-SG 05). Pract Radiat Oncol. 2024 Sep-Oct;14(5):e344-e352. doi: 10.1016/j.prro.2024.04.022. Epub 2024 Jun 29. |
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Analyze toxicities in every patient during the first 3 months after the treatment with SBRT. Every significant Adverse Event will be graded as CTC-AE v.4.03. For Pain related adverse events, visual analogic scale (VAS) will be used. |
| 3 months after the SBRT treatment |
| Free disease progression survival measured with Kaplan-Meier method | the time to disease progression will be defined as the time between the date when the patient is treated with SBRT and the date of biochemical (PSA increased upper to 2 ng/mL) o radiological progression or the last follow-up visit. | the patients will be followed up an expected average of 5 years |
| Quality of life questionnaire FACT-P | The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment. | baseline and 3rd month after the SBRT treatment. |
| Majadahonda |
| Madrid |
| Spain |
| Hospital Rey Juan Carlos | Móstoles | Madrid | Spain |
| Santa Lucia | Cartagena | Murcia | Spain |
| Instituto catalan de Oncología | Barcelona | Spain |
| Hospital de Cruces | Bilbao | Spain |
| C.H.P. Castellón | Castellon | Spain |
| Hospital Dr. Negrin | Las Palmas de Gran Canaria | Spain |
| Clínica QUIRON | Madrid | Spain |
| Hospital central de la defensa Gomez Ulla | Madrid | Spain |
| Hospital de Sanchinarro | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Ruber Internacional | Madrid | Spain |
| Hospital Universitario de la Princesa | Madrid | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital de Navarra | Navarro | Spain |
| Hospital Universitario Clínico de Salamanca | Salamanca | Spain |
| Hospital marques de Valdecilla | Santander | Spain |
| ERESA H. General de Valencia | Valencia | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | Spain |
| Hospital Do Mexoeiro | Vigo | Spain |
| Hospital Miguel Servet | Zaragoza | Spain |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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