Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
1 other identifier
interventional
68
1 country
22
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2014
CompletedFirst Posted
Study publicly available on registry
July 17, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 19, 2021
November 1, 2021
6.9 years
July 3, 2014
November 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients without disease progression of prostate cancer treated by SBRT
Number of patients without disease progression of local and symptomatic oligometastases of prostate cancer treated by SBRT expressed as total number and percentage
5 years
Secondary Outcomes (4)
Overall Survival measured with Kaplan-Meier method
patients will be followed up an average of 5 years
Number of patients with an adverse events.
3 months after the SBRT treatment
Free disease progression survival measured with Kaplan-Meier method
the patients will be followed up an expected average of 5 years
Quality of life questionnaire FACT-P
baseline and 3rd month after the SBRT treatment.
Study Arms (1)
SBRT
EXPERIMENTALStereotactic Body Radiation Therapy for Oligometastases (SBRT)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
- Patients unwilling or unable to comply with protocol requirements and scheduled visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
GICOR
Madrid, Las Rozas, 28290, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Santa Lucia
Cartagena, Murcia, Spain
Instituto catalan de Oncología
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
C.H.P. Castellón
Castellon, Spain
Hospital Dr. Negrin
Las Palmas de Gran Canaria, Spain
Clínica QUIRON
Madrid, Spain
Hospital central de la defensa Gomez Ulla
Madrid, Spain
Hospital de Sanchinarro
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Ruber Internacional
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital de Navarra
Navarro, Spain
Hospital Universitario Clínico de Salamanca
Salamanca, Spain
Hospital marques de Valdecilla
Santander, Spain
ERESA H. General de Valencia
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Do Mexoeiro
Vigo, Spain
Hospital Miguel Servet
Zaragoza, Spain
Related Publications (1)
Conde-Moreno AJ, Lopez-Campos F, Hervas A, Morillo V, Mendez A, Puertas MDM, Valero-Albarran J, Gomez Iturriaga A, Rico M, Vazquez ML, Samper Ots PM, Perez-Romasanta LA, Pastor J, Ibanez C, Ferrer F, Zapatero A, Garcia-Blanco AS, Rodriguez A, Ferrer C. A Phase II Trial of Stereotactic Body Radiation Therapy and Androgen Deprivation for Oligometastases in Prostate Cancer (SBRT-SG 05). Pract Radiat Oncol. 2024 Sep-Oct;14(5):e344-e352. doi: 10.1016/j.prro.2024.04.022. Epub 2024 Jun 29.
PMID: 38944806DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio J Conde Moreno, MD
Grupo de Investigación Clínica en Oncología Radioterapia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 3, 2014
First Posted
July 17, 2014
Study Start
August 1, 2014
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
November 19, 2021
Record last verified: 2021-11