Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer

NCT ID: NCT07344844

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-18
• Study Completion Date: 2029-05-01

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients treated by SBRT with pre-session low-dose CT

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.

Group Type: OTHER

Low-dose CT imaging before each SBRT session

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Sainte Clotilde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youssef Slama

Role: STUDY_CHAIR

Clinique Sainte Clotilde

Locations

Clinique Sainte Clotilde

Saint-Denis, , Reunion

Site Status: RECRUITING

Countries

Reunion

Central Contacts

MANON Leprince, Clinical Research Associate

Role: CONTACT

manon.leprince@clinifutur.net

0692341365

Mickael Begue, Principal Investigator

Role: CONTACT

manon.leprince@clinifutur.net

Facility Contacts

MANON LEPRINCE

Role: primary

manon.leprince@clinifutur.net

0692341365

Other Identifiers

2025-A00339-40

Identifier Type: -

Identifier Source: org_study_id