An interventional study of Prostate SBRT (stereotactic body radiation therapy) with focal boost in Prostate Adenocarcinoma, sponsored by Almudena Zapatero. Recruiting at 1 site in Spain. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Almudena Zapatero · Not applicable, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 27 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →This is the only study on the registry with Almudena Zapatero as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost
* 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
Also known as: SABR with SIB, SBRT focal intensification
Biochemical progression-free survival
Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
Time frame: 3 years
Local control
Disappearance of suspicious image on mpMRI.
Time frame: 12 months
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)
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
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)
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
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)
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
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)
Time frame: 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
Time frame: 2 years
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