Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
|ClinicalTrials.gov Identifier: NCT02192788|
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : August 4, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Oligometastatic Prostate Cancer||Radiation: Stereotactic Body Radiation Therapy for Oligometastases||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2019|
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
|Radiation: Stereotactic Body Radiation Therapy for Oligometastases|
- 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
- Overall Survival measured with Kaplan-Meier method [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192788
|Contact: Antonio J Conde Moreno, MD||0034 964354342|
|Hospital Provincial de Castellón||Recruiting|
|Castellon, Castellón, Spain, 12002|
|Contact: Antonio J Conde Moreno, MD 0034 964354342|
|Contact: Francisco Garcia-Pinon 0034 964354525 firstname.lastname@example.org|
|Principal Investigator: Antonio J Conde Moreno, MD|
|Sub-Investigator: Carlos Ferrer Albiach, MD|
|Sub-Investigator: Angel L Sanchez Iglesias, MD|
|Sub-Investigator: Rodrigo Muelas Soria, MD|
|Sub-Investigator: Maria Albert Antequera, MD|