Oligometastatic Prostate Cancer
Conditions
Keywords
SBRT, Oligometastases, Prostate Cancer
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
Interventions
RADIATIONStereotactic Body Radiation Therapy for Oligometastases
Sponsors
Grupo de Investigación Clínica en Oncología Radioterapia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients without disease progression of prostate cancer treated by SBRT | 5 years | Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival measured with Kaplan-Meier method | patients will be followed up an average of 5 years | 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. |
| Number of patients with an adverse events. | 3 months after the SBRT treatment | 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. |
| Free disease progression survival measured with Kaplan-Meier method | the patients will be followed up an expected average of 5 years | 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. |
| Quality of life questionnaire FACT-P | baseline and 3rd month after the SBRT treatment. | The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment. |
Countries
Spain
Outcome results
None listed