Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT02192788 |
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Recruitment Status : Unknown
Verified April 2019 by Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia.
Recruitment status was: Active, not recruiting
First Posted : July 17, 2014
Last Update Posted : April 25, 2019
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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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer |
| Study Start Date : | August 2014 |
| Actual Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | August 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SBRT
Stereotactic Body Radiation Therapy for Oligometastases (SBRT)
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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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
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
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| Responsible Party: | Antonio J Conde Moreno, MD, Grupo de Investigación Clínica en Oncología Radioterapia |
| ClinicalTrials.gov Identifier: | NCT02192788 |
| Other Study ID Numbers: |
SBRT-SG 05 |
| First Posted: | July 17, 2014 Key Record Dates |
| Last Update Posted: | April 25, 2019 |
| Last Verified: | April 2019 |
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SBRT Oligometastases Prostate Cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |