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

N/ACompletedNCT02192788

Grupo de Investigación Clínica en Oncología Radioterapia68 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oligometastatic Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

GICOR

Madrid, Las Rozas, Spain

Hospital Puerta de Hierro

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

...and 12 more locations

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline and 3rd month after the SBRT treatment.