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

Not Applicable

Completed

• Conditions: Oligometastatic Prostate Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy for Oligometastases

• Registration Number: NCT02192788
• Lead Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Study Start: 2014-08
• Primary Completion: 2021-07
• Study Completion: 2021-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT	Stereotactic Body Radiation Therapy for Oligometastases	Stereotactic Body Radiation Therapy for Oligometastases (SBRT)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (22)

Hospital Dr. Negrin; 🇪🇸 Las Palmas De Gran Canaria, Spain

GICOR; 🇪🇸 Madrid, Las Rozas, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Santa Lucia; 🇪🇸 Cartagena, Murcia, Spain

Hospital de Cruces; 🇪🇸 Bilbao, Spain

Hospital central de la defensa Gomez Ulla; 🇪🇸 Madrid, Spain

Hospital Rey Juan Carlos; 🇪🇸 Móstoles, Madrid, Spain

Hospital Universitario Clínico de Salamanca; 🇪🇸 Salamanca, Spain

ERESA H. General de Valencia; 🇪🇸 Valencia, Spain

Clínica QUIRON; 🇪🇸 Madrid, Spain

C.H.P. Castellón; 🇪🇸 Castellón De La Plana, Spain

Instituto catalan de Oncología; 🇪🇸 Barcelona, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Do Mexoeiro; 🇪🇸 Vigo, Spain

Hospital Universitario de la Princesa; 🇪🇸 Madrid, Spain

Hospital de Navarra; 🇪🇸 Navarro, Spain

Hospital Ruber Internacional; 🇪🇸 Madrid, Spain

Hospital marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital de Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain