Prostate Cancer (Adenocarcinoma)SPARNCT07344844
Adaptive Stereotactic Radiotherapy for Localized Prostate Cancer
A study testing Low-dose CT imaging before each SBRT session in people with Prostate Cancer (Adenocarcinoma), run by Clinique Sainte Clotilde at 1 site in Reunion.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Low-dose CT imaging before each SBRT session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteReunion
- Study dates
- 18 Nov 2025to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Affiliated with or benefiting from a French social security system
- French-speaking patient
- Patient appropriately informed and having signed a written informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mickael Begue, Principal Investigator contact
Reunion1 site, 1 recruiting
- Recruiting
Clinique Sainte Clotilde
Saint-Denis, 97404
MANON LEPRINCE, 0692341365, manon.leprince@clinifutur.net
Mickael Begue, Doctor
About this study
Official title: Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
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)
- Being tested
- Low-dose CT imaging before each SBRT session
- Keywords
- SBRT, Cyberknife, radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT imaging before each SBRT sessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by SBRT with pre-session low-dose CT | 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. Receives: Other: Low-dose CT imaging before each SBRT session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients requiring dosimetric recalculation due to anatomical variations
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.
Measured: At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.
Secondary outcomes (6)
Cumulative delivered dose to Organs at Risk (OARs)
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
Measured: 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)
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.
Measured: Time Frame: Baseline (pre-radiotherapy) 1 month 3 months 6 months 12 months 18 months 24 months post-radiotherapy
Survival outcomes
Overall Survival (OS): Death from any cause.
Measured: 1, 3, 6, 12, 18, 24 months post-radiotherapy
Recurrence-Free Survival (RFS)
Clinical, biochemical, or radiological recurrence.
Measured: 1, 3, 6, 12, 18, 24 months post-radiotherapy
Change from baseline in prostate cancer-specific quality of life (EORTC QLQ-PR25)
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.
Measured: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy
Change from baseline in urinary symptoms (IPSS)
Change from baseline in urinary symptoms assessed using the International Prostate Symptom Score (IPSS).
Score range: 0-35 Higher scores indicate worse urinary symptoms.
Measured: Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start18 Nov 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Sainte Clotilde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef Slama, Study chair, Clinique Sainte Clotilde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344844
- Sponsor's protocol ID
- 2025-A00339-40
- Acronym
- SPAR
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
- ClinicalTrials.gov ID
- NCT07344844
- Acronym / sponsor ID
- SPAR / 2025-A00339-40
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- SBRT, Cyberknife, radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clinique Sainte ClotildeUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by SBRT with pre-session low-dose CT | Other | Other: Low-dose CT imaging before each SBRT sessionFive 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose CT imaging before each SBRT sessionFive 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. | Other | Patients treated by SBRT with pre-session low-dose CT |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mickael Begue, Principal Investigator contact
Youssef Slama study chair
Clinique Sainte Clotilde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT imaging before each SBRT session in people with Prostate Cancer (Adenocarcinoma), run by Clinique Sainte Clotilde at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MANON Leprince, Clinical Research Associate (0692341365, manon.leprince@clinifutur.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.