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Recruiting NCT07344844

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

No phase Interventional Prostate Cancer (Adenocarcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose CT imaging before each SBRT session.
Who it may be relevant to
Registry conditions: Prostate Cancer (Adenocarcinoma). Basic parameters: from 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Reunion
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique

Overview

This study evaluates whether adaptive stereotactic body radiotherapy (SBRT) provides dosimetric advantages compared to non-adaptive SBRT in localized prostate cancer. Five low-dose CT scans are performed before each SBRT session to assess anatomical variations (bladder filling, rectal volume) and determine if a dosimetric recalculation would have been required. The study also evaluates cumulative dose to organs at risk, patient-reported quality of life over 24 months, and overall and recurrence-free survival.

Interventions

  • Other Low-dose CT imaging before each SBRT session
    Five low-dose, non-contrast CT scans performed immediately before each SBRT session (≈10 min before treatment) to assess anatomical variations impacting target volume and organ-at-risk dosimetry.

Primary outcome measures

  • Proportion of patients requiring dosimetric recalculation due to anatomical variations [Time frame: At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.]
Secondary outcome measures (6)
  • Cumulative delivered dose to Organs at Risk (OARs) [Time frame: From baseline CT + all 5 fraction low-dose CT scans. (up to 10 days)]
  • Change from baseline in global quality of life (EORTC QLQ-C30) [Time frame: Time Frame: Baseline (pre-radiotherapy) 1 month 3 months 6 months 12 months 18 months 24 months post-radiotherapy]
  • Survival outcomes [Time frame: 1, 3, 6, 12, 18, 24 months post-radiotherapy]
  • Recurrence-Free Survival (RFS) [Time frame: 1, 3, 6, 12, 18, 24 months post-radiotherapy]
  • Change from baseline in prostate cancer-specific quality of life (EORTC QLQ-PR25) [Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy]
  • Change from baseline in urinary symptoms (IPSS) [Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy]

Eligibility criteria

Inclusion criteria

  • Male aged ≥60 years
  • Localized prostate cancer of low or intermediate risk (T1-T2)
  • Gleason score 6-7
  • PSA <15 ng/mL
  • No evidence of metastatic disease
  • Radiotherapy indicated for prostate cancer
  • Affiliated with or benefiting from a French social security system
  • French-speaking patient
  • Patient appropriately informed and having signed a written informed consent form

Exclusion criteria

  • Unable to read, write, or understand French
  • Vulnerable patient as defined by Article L1121-6 of the French Public Health Code
  • Adult under guardianship, curatorship, or legal protection ("sauvegarde de justice")
  • Patient unable to personally provide informed consent according to Article L1121-8 of the French Public Health Code
  • Patient already included in another interventional study that could interfere with study outcomes
  • History of urological (prostate) or digestive surgery that could influence study outcomes
  • Refusal to sign the written informed consent form

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Reunion · 1 center
  • Clinique Sainte Clotilde — Saint-Denis

Identifiers

NCT: NCT07344844 · 2025-A00339-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗