Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oligometastatic Prostate Cancer
- Sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Enrollment
- 68
- Locations
- 22
- Primary Endpoint
- Number of patients without disease progression of prostate cancer treated by SBRT
- Status
- Completed
- Last Updated
- 4 years ago
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
Investigators
Antonio J Conde Moreno
MD
Grupo de Investigación Clínica en Oncología Radioterapia
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.
Outcomes
Primary Outcomes
Number of patients without disease progression of prostate cancer treated by SBRT
Time Frame: 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 Outcomes
- Number of patients with an adverse events.(3 months after the SBRT treatment)
- Free disease progression survival measured with Kaplan-Meier method(the patients will be followed up an expected average of 5 years)
- Overall Survival measured with Kaplan-Meier method(patients will be followed up an average of 5 years)
- Quality of life questionnaire FACT-P(baseline and 3rd month after the SBRT treatment.)