Clinical trial · Interventional
SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate SBRT (stereotactic body radiation therapy) with focal boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT with mpMRI guided focal boost
- description
- 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.
- interventionNames
- Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost
Primary outcomes (2)
- measure
- Biochemical progression-free survival
- timeFrame
- 3 years
- description
- Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
- measure
- Local control
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDZapatero 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. PMID 38702761