SBRT With Focal Dose Escalation on DIL in Localized Prostate Cancer

NCT05919524 | Unknown DMC

• 1 other identifier: SBRT Focal SAFO
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Biochemical progression-free survival

  Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)

  3 years

• Local control

  Disappearance of suspicious image on mpMRI.

  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

  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

  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

  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

  2 years

• Patient reported outcomes and quality of life assessment

  2 years

Study Arms (1)

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.

Radiation: Prostate SBRT (stereotactic body radiation therapy) with focal boost

Interventions

Prostate SBRT (stereotactic body radiation therapy) with focal boost RADIATION

* 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

SBRT with mpMRI guided focal boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Almudena Zapatero: lead

Study Sites (1)

La Princesa University Hospital, Health Research Institute, Madrid

Madrid, 28006, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 38702761 DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Almudena Zapatero, PhD

CONTACT

+34915202315; almudena.zapatero@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor

Model Details: Single group assignment

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 26, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: June 30, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

ES (1)