Oligometastatic Prostate CancerNCT02192788
Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
A study testing Stereotactic Body Radiation Therapy for Oligometastases in people with Oligometastatic Prostate Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 22 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy for Oligometastases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 22 sitesSpain
- Study dates
- Aug 2014to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
- Patients unwilling or unable to comply with protocol requirements and scheduled visits.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Instituto catalan de Oncología
Barcelona
Hospital de Cruces
Bilbao
Santa Lucia
Cartagena, Murcia
C.H.P. Castellón
Castellon
Hospital Dr. Negrin
Las Palmas de Gran Canaria
GICOR
Madrid, Las Rozas, 28290
Clínica QUIRON
Madrid
Hospital central de la defensa Gomez Ulla
Madrid
Hospital de Sanchinarro
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Ruber Internacional
Madrid
Hospital Universitario de la Princesa
Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid
Hospital Rey Juan Carlos
Móstoles, Madrid
Hospital Virgen de la Arrixaca
Murcia
Hospital de Navarra
Navarro
Hospital Universitario Clínico de Salamanca
Salamanca
Hospital marques de Valdecilla
Santander
ERESA H. General de Valencia
Valencia
Hospital Universitari i Politècnic La Fe
Valencia
Hospital Do Mexoeiro
Vigo
Hospital Miguel Servet
Zaragoza
About this study
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
- Conditions
- Oligometastatic Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy for Oligometastases
- Keywords
- SBRT, Oligometastases, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy for OligometastasesRadiation
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | Stereotactic Body Radiation Therapy for Oligometastases (SBRT) Receives: Radiation: Stereotactic Body Radiation Therapy for Oligometastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (4)
Overall Survival measured with Kaplan-Meier method
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.
Measured: patients will be followed up an average of 5 years
Number of patients with an adverse events.
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.
Measured: 3 months after the SBRT treatment
Free disease progression survival measured with Kaplan-Meier method
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.
Measured: the patients will be followed up an expected average of 5 years
Quality of life questionnaire FACT-P
The Functional Assessment Of Cancer Therapy-Prostate Questionnaire (FACT-P) will be performed at baseline and 3 months after the SBRT treatment.
Measured: baseline and 3rd month after the SBRT treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio J Conde Moreno, Grupo de Investigación Clínica en Oncología Radioterapia
- Investigators
- Antonio J Conde Moreno, MD, Principal investigator, Grupo de Investigación Clínica en Oncología Radioterapia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192788
- Sponsor's protocol ID
- SBRT-SG 05
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2014
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38944806
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of SBRT as Treatment for Oligometastases in Prostate Cancer
- ClinicalTrials.gov ID
- NCT02192788
- Acronym / sponsor ID
- SBRT-SG 05
- Conditions
- Oligometastatic Prostate Cancer
- Keywords
- SBRT, Oligometastases, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: Stereotactic Body Radiation Therapy for OligometastasesStereotactic Body Radiation Therapy for Oligometastases (SBRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes.
- Patients unwilling or unable to comply with protocol requirements and scheduled visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy for Oligometastases | Radiation | SBRT |
Primary outcome
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
4 secondary outcomes
Overall Survival measured with Kaplan-Meier method
Time frame: patients will be followed up an average of 5 years
Number of patients with an adverse events.
Time frame: 3 months after the SBRT treatment
Free disease progression survival measured with Kaplan-Meier method
Time frame: the patients will be followed up an expected average of 5 years
Quality of life questionnaire FACT-P
Time frame: baseline and 3rd month after the SBRT treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 38944806Conde-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.
Related trials for Oligometastatic Prostate Cancer
RecruitingPhase 1
JUR-003 in Adult Patients With Metastatic Prostate Cancer
Metastatic Castration Resistant Prostate Cancer, Oligometastatic Prostate Cancer (OMPC)
RecruitingPhase 3
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Oligometastatic Prostate Cancer (OMPC)
Active, not recruitingPhase 2
A Study To Evaluate Hypofractionated Proton Therapy Or IMRT For Recurrent, Oligometastatic Prostate Cancer
Metastatic Prostate Adenocarcinoma, Oligometastatic Prostate Carcinoma
Active, not recruitingPhase 1
[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Recruiting
Addressing Health Literacy With a Tailored Survivorship Care Plan
Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio J Conde Moreno, MD principal investigator
Grupo de Investigación Clínica en Oncología Radioterapia
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy for Oligometastases in people with Oligometastatic Prostate Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients without disease progression of prostate cancer treated by SBRT (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02192788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.