Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|