Prostate AdenocarcinomaSAFONCT05919524
SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
A study testing Prostate SBRT (stereotactic body radiation therapy) with focal boost in people with Prostate Adenocarcinoma, run by Almudena Zapatero at 1 site in Spain.
Trial summary
Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Prostate SBRT (stereotactic body radiation therapy) with focal boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 30 Jun 2025
- 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
- Histologically confirmed adenocarcinoma of the prostate
- Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023
- Signed written informed consent for this study
- T2-T3a clinical stage with visible DIL on mpMRI
- ECOG 0-1
- Desirable prostate volume (not mandatory) < 80 cc or > 80 cc if urinary function is preserved and dosimetrically feasible
- IPSS ≤ 18 (International Prostate Symptom Score)
Who cannot join
- Unresolved previous prostatitis, symptomatic urethral stenosis
- Bilateral hip prosthesis
- T3b-4 clinical stage or N1
- M1 (presence of distant metastases)
- Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Princesa University Hospital, Health Research Institute, Madrid
Madrid, 28006
Almudena Zapatero, PhD, +34915202315, almudena.zapatero@salud.madrid.org
Almudena Zapatero, PhD
About this study
Official title: Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects.
On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate.
Read more
The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice.
This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Prostate SBRT (stereotactic body radiation therapy) with focal boost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate SBRT (stereotactic body radiation therapy) with focal boostRadiation
Also called SABR with SIB, SBRT focal intensification
- Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions of 7.25 Gy to the entire prostate (including seminal vesicles) using VMAT
- mpMRI defined DIL was simultaneously boosted up to 50 Gy in 5 sessions to the mpMRI identified DIL.
- Additional urethra and bladder trigone sparing constrains
- Daily IGRT with cone beam CT and intrafraction gold-seeds fiducial tracking
| Study group | Role | What they receive |
|---|---|---|
| SBRT with mpMRI guided focal boost | Experimental | SBRT 36.25 Gy in 5 sessions of 7.25 Gy to the entire prostate (including seminal vesicles) with a DIL simultaneous integrated focal boost (SIB) up to 50 Gy in 5 sessions, with partial protection of the prostatic urethra and bladder trigone. Receives: Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical progression-free survival
Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
Measured: 3 years
Local control
Disappearance of suspicious image on mpMRI.
Measured: 12 months
Secondary outcomes (5)
Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Every urinary event occurring within 3 months from treatment completion will be defined as "acute event".
All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Measured: 90 days
Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Every rectal event occurring within 3 months from treatment completion will be defined as "acute event".
All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Measured: 90 days
Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Every urinary event occurring after 3 months from treatment completion will be defined as "late event".
All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Measured: 2 years
Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Every rectal event occurring after 3 months from treatment completion will be defined as "late event".
All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Measured: 2 years
Patient reported outcomes and quality of life assessment
Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EPIC-26 short form (International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite-26
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
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 Prostate AdenocarcinomaStudies 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
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almudena Zapatero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Almudena Zapatero, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919524
- Sponsor's protocol ID
- SBRT Focal SAFO
- Acronym
- SAFO
- Status last verified
- Sep 2023
- First submitted
- 5 Jun 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zapatero A, Castro P, Roch M, Carnero PR, Carroceda S, Rosciupchin AES, Hernandez SH, Cogorno L, Iturriaga AG, Garcia DB. Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial. Radiat Oncol. 2024 May 3;19(1):54. doi: 10.1186/s13014-024-02440-7.
PubMed 38702761
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT05919524
- Acronym / sponsor ID
- SAFO / SBRT Focal SAFO
- Conditions
- Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Almudena ZapateroUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Jun 2023 (actual)
- 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.
Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects.
On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate.
The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice.
This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| SBRT with mpMRI guided focal boost | Experimental | Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boostSBRT 36.25 Gy in 5 sessions of 7.25 Gy to the entire prostate (including seminal vesicles) with a DIL simultaneous integrated focal boost (SIB) up to 50 Gy in 5 sessions, with partial protection of the prostatic urethra and bladder trigone. |
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)
- Histologically confirmed adenocarcinoma of the prostate
- Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023
- Signed written informed consent for this study
- T2-T3a clinical stage with visible DIL on mpMRI
- ECOG 0-1
Key exclusion criteria (5 listed)
- Unresolved previous prostatitis, symptomatic urethral stenosis
- Bilateral hip prosthesis
- T3b-4 clinical stage or N1
- M1 (presence of distant metastases)
- Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months
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 |
|---|---|---|
| Prostate SBRT (stereotactic body radiation therapy) with focal boostAlso: SABR with SIB, SBRT focal intensification* Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions of 7.25 Gy to the entire prostate (including seminal vesicles) using VMAT * mpMRI defined DIL was simultaneously boosted up to 50 Gy in 5 sessions to the mpMRI identified DIL. * Additional urethra and bladder trigone sparing constrains * Daily IGRT with cone beam CT and intrafraction gold-seeds fiducial tracking | Radiation | SBRT with mpMRI guided focal boost |
Primary outcome
Biochemical progression-free survival
Time frame: 3 years
Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
Local control
Time frame: 12 months
Disappearance of suspicious image on mpMRI.
5 secondary outcomes
Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Time frame: 90 days
Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Time frame: 90 days
Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Time frame: 2 years
Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
Time frame: 2 years
Patient reported outcomes and quality of life assessment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 38702761Zapatero A, Castro P, Roch M, Carnero PR, Carroceda S, Rosciupchin AES, Hernandez SH, Cogorno L, Iturriaga AG, Garcia DB. Functional imaging guided stereotactic ablative body radiotherapy (SABR) with focal dose escalation and bladder trigone sparing for intermediate and high-risk prostate cancer: study protocol for phase II safo trial. Radiat Oncol. 2024 May 3;19(1):54. doi: 10.1186/s13014-024-02440-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate SBRT (stereotactic body radiation therapy) with focal boost in people with Prostate Adenocarcinoma, run by Almudena Zapatero at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Almudena Zapatero, PhD (+34915202315, almudena.zapatero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical progression-free survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05919524, 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 26 Sep 2023.