Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer

Conditions
-----------------
Oligometastatic Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Stereotactic Body Radiation Therapy for Oligometastases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease. Aged ≥ 18 years Time to biochemical recurrence more than 1 year PSA doubling time> 3 months Less than 5 bone metastases location (including spinal) or lymph node. Without other metastases or recurrences by Choline PET or / and NMR Diffusion Length. Signed and dated written informed consent form. Exclusion Criteria: Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes. Patients unwilling or unable to comply with protocol requirements and scheduled visits.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT<br>Stereotactic Body Radiation Therapy for Oligometastases (SBRT) | Radiation: Stereotactic Body Radiation Therapy for Oligometastases<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SBRT, Oligometastases, Prostate Cancer