SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost
- Registration Number
- NCT05919524
- Lead Sponsor
- Almudena Zapatero
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 27
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SBRT with mpMRI guided focal boost Prostate SBRT (stereotactic body radiation therapy) with focal boost 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.
- Primary Outcome Measures
Name Time Method Local control 12 months Disappearance of suspicious image on mpMRI.
Biochemical progression-free survival 3 years Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
- Secondary Outcome Measures
Name Time Method Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale 2 years 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)Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale 90 days 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)Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale 90 days 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)Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale 2 years 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)Patient reported outcomes and quality of life assessment 2 years 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
Trial Locations
- Locations (1)
La Princesa University Hospital, Health Research Institute, Madrid
🇪🇸Madrid, Spain