Clinical trial NCT05919524: SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer
Official title: Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biochemical progression-free survival
timeFrame: 3 years
measure: Local control
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
timeFrame: 90 days
measure: Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
timeFrame: 90 days
measure: Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
timeFrame: 2 years
measure: Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale
timeFrame: 2 years
measure: Patient reported outcomes and quality of life assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Princesa University Hospital, Health Research Institute, Madrid
Study officials:
References: