Clinical trial NCT02192788: Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Official title: Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligometastatic Prostate Cancer
Keywords: SBRT
Oligometastases
Prostate Cancer
Lead sponsor: Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of patients without disease progression of prostate cancer treated by SBRT
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival measured with Kaplan-Meier method
timeFrame: patients will be followed up an average of 5 years
measure: Number of patients with an adverse events.
timeFrame: 3 months after the SBRT treatment
measure: Free disease progression survival measured with Kaplan-Meier method
timeFrame: the patients will be followed up an expected average of 5 years
measure: Quality of life questionnaire FACT-P
timeFrame: baseline and 3rd month after the SBRT treatment.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: GICOR
state: Las Rozas
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
city: Cartagena
country: Spain
facility: Santa Lucia
state: Murcia
city: Barcelona
country: Spain
facility: Instituto catalan de Oncología
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Castellón De La Plana
country: Spain
facility: C.H.P. Castellón
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Dr. Negrin
city: Madrid
country: Spain
facility: Clínica QUIRON
city: Madrid
country: Spain
facility: Hospital central de la defensa Gomez Ulla
city: Madrid
country: Spain
facility: Hospital de Sanchinarro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Navarro
country: Spain
facility: Hospital de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario Clínico de Salamanca
city: Santander
country: Spain
facility: Hospital marques de Valdecilla
city: Valencia
country: Spain
facility: ERESA H. General de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Vigo
country: Spain
facility: Hospital Do Mexoeiro
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
name: Antonio J Conde Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References: