Actively Recruiting

Phase Not Applicable
Age: 60Years +
MALE
ID07344844

Interest of Adaptive Stereotactic Radiotherapy in Localized Prostate Cancer

Led by Clinique Sainte Clotilde · Updated on 2026-01-15

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adaptive stereotactic body radiotherapy (SBRT) offers advantages over non-adaptive SBRT for treating localized prostate cancer in men aged 60 years and older. The study focuses on how anatomical changes, such as bladder filling and rectal volume, might affect radiation dosing. It also examines the overall dose delivered to nearby organs, patient quality of life over two years, and survival without cancer recurrence. Participants receive five low-dose, non-contrast CT scans taken immediately before each SBRT session to check for anatomical changes that could impact treatment. These scans help determine if recalculating the radiation dose is necessary to better target the prostate and protect surrounding organs. The study tracks these measurements across all five treatment sessions within approximately ten days. Throughout the study, patients report on their quality of life and urinary symptoms before treatment and at several points up to 24 months after radiotherapy. Researchers monitor survival and cancer recurrence at multiple intervals within the two-year follow-up. Participants are carefully informed and provide consent, with ongoing evaluations to assess treatment impact and safety over time.

CONDITIONS

Brief Title

Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

Who Can Participate

Age: 60Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 60 years or older
  • Localized prostate cancer of low or intermediate risk (T1-T2)
  • Gleason score 6-7
  • PSA level less than 15 ng/mL
  • No evidence of metastatic disease
  • Radiotherapy indicated for prostate cancer
  • Affiliated with or benefiting from French social security
  • French-speaking patient
  • Patient informed and signed written consent
Not Eligible

You will not qualify if you...

  • Unable to read, write, or understand French
  • Vulnerable patient as defined by French Public Health Code
  • Adult under guardianship, curatorship, or legal protection
  • Unable to personally provide informed consent
  • Currently enrolled in another interventional study that may interfere
  • History of urological or digestive surgery affecting outcomes
  • Refusal to sign written informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 10 days

Participants undergo five low-dose CT scans immediately before each stereotactic body radiotherapy (SBRT) session to assess anatomical variations affecting treatment planning.

5 visits (in-person, before each SBRT session)

Long-term Monitoring

Duration - 24 months post-radiotherapy

Participants are monitored for changes in quality of life, urinary symptoms, survival, and recurrence-free survival after radiotherapy.

Visits at baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy

Trial Site Locations

Total: 1 location

1

Clinique Sainte Clotilde

Saint-Denis, Reunion, 97404

Actively Recruiting

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Research Team

M

MANON Leprince, Clinical Research Associate

M

Mickael Begue, Principal Investigator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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