Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07344844

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Sainte Clotilde

Saint-Denis, 97404, Reunion

Location status: Recruiting

Location contact

Fabien Dutheil, Doctor

SUB_INVESTIGATOR

Gilles Baumont, Doctor

SUB_INVESTIGATOR

MANON LEPRINCE

CONTACT

[email protected]

0692341365

Mickael Begue, Doctor

PRINCIPAL_INVESTIGATOR

Olivier Maillot, Doctor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose CT imaging before each SBRT session

Other

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 outcomes

  1. 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.

    Percentage of patients for whom at least one stereotactic body radiotherapy (SBRT) fraction would have required a dosimetric recalculation due to anatomical variations (bladder filling and/or rectal emptying), based on comparison between the initial treatment plan and pre-treatment low-dose CT scans acquired before each SBRT fraction (5).

    This outcome reflects the potential benefit of an adaptive radiotherapy approach compared to a non-adaptive strategy.

Secondary outcomes

  1. Cumulative delivered dose to Organs at Risk (OARs)

    Time frame: From baseline CT + all 5 fraction low-dose CT scans. (up to 10 days)

    Definition:

    Quantitative assessment of the dose actually delivered to each OAR across all fractions, based on dose-volume parameters derived from the low-dose CTs and DVH (Dose-Volume Histogram) analyses.

    OARs and parameters include:

    Rectum Maximum dose (0.03 cc) Dose to 3 cc Dose to 10%, 20%, and 50% of the volume

    Bladder Maximum dose (0.03 cc) Dose to 10% and 50% of the volume Penile bulb Maximum dose Dose to 3 cc

    Femoral heads Dose to 10 cc (combined left and right) Maximum dose

    Bowel (GETUG-14 constraints) D5cc D1cc

    Urethra Maximum dose

  2. 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

    Change from baseline in global quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

    Score range: 0-100 Higher scores indicate better quality of life.

  3. Survival outcomes

    Time frame: 1, 3, 6, 12, 18, 24 months post-radiotherapy

    Overall Survival (OS): Death from any cause.

  4. Recurrence-Free Survival (RFS)

    Time frame: 1, 3, 6, 12, 18, 24 months post-radiotherapy

    Clinical, biochemical, or radiological recurrence.

  5. 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 prostate cancer-specific quality of life domains assessed using the EORTC QLQ-PR25 questionnaire.

    Score range: 0-100 Higher scores indicate worse symptoms.

  6. Change from baseline in urinary symptoms (IPSS)

    Time frame: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy

    Change from baseline in urinary symptoms assessed using the International Prostate Symptom Score (IPSS).

    Score range: 0-35 Higher scores indicate worse urinary symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

MANON Leprince, Clinical Research Associate

CONTACT

[email protected]

0692341365

Mickael Begue, Principal Investigator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Clinique Sainte Clotilde

Other

Registry information

Official study title

Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique

Acronym: SPAR

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.