Prostate CancerFOCUS-BOOSTNCT05322356
Prostate Interstitial Brachytherapy With I125 Implant With Target Dose Supplementation in the Tumor Volume Guided by TRINITY® PERINE 3D System
A study testing Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D in people with Prostate Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2023to Sep 2026
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years
- Patient to be treated with brachytherapy
- Patient with low or favorable intermediate risk prostate adenocarcinoma ISUP 1 and 2, G6 (3+3) or G7 (3+4)
- Life expectancy of more than 10 years
- PSA (prostate-specific antigen) < 15 ng/ml
- cT1c or cT2a or cT2b
Show all 10Show fewer
- Prostate volume ≤ 60 cc
- ECOG Performance status 0-2
- Patient is affiliated to a health insurance system
- Patient who has signed consent form
Who cannot join
- Patient with urinary function disorders IPSS> 14
- Prostate volume > 60cc.
- Gleason 7(4+3) or Gleason score ≥8
- PSA ≥ 15 ng/ml
- Patient with metastases
- Hormone therapy with antiandrogen or LHRH analogue
Show all 10Show fewer
- History of abdominopelvic irradiation
- Inflammatory digestive disease (haemorrhagic rectocolitis, Crohn's disease)
- Interventional study in progress that may interfere with the present study
- Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D Ultrasound System
The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.
Read the detailed description
The interstitial brachytherapy procedure for the prostate does not allow for a robust focal treatment to accurately deliver additional dose to the tumour volume. FOCUS BOOST allows the precise implantation of 125 iodine implant with greater accuracy (using a 3D ultrasound image fusion registration system) in a target volume.
For this purpose, positive biopsies, performed in this research protocol, will be used prior to surgery. Prostate brachytherapy will be optimised thanks to the TRINITY® system and its guidance quality, by increasing the dose of the intra-prostate tumour volume (BOOST) without increasing the total dose delivered to the prostate. Increasing the dose to the tumour target volume could improve disease control and decrease the risk of recurrence.
- Conditions
- Prostate Cancer
- Being tested
- Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D
- Keywords
- Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3DOther
Target dose supplement with the TRINITY® PERINE 3D system
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D system Receives: Other: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.
To evaluate the number of successful/failed iodine 125 implants (BOOST implants) implanted in the CTV-boost (Clinical Target Volume) defined from the mapping of positive biopsies.
The maximum number of BOOST implant implanted will be 4 implants, depending on the size of the target:
10 mm< target ≤ 15 mm = 2 implants; 15 mm < target ≤ 20mm = 3 implants; 20 mm < target ≤ 30 mm = 4 implants; Success is defined as "the centre of the implant is in the target volume". Failure is defined as "the centre of the implant is outside the target volume". The primary endpoint is evaluated on the ultrasound acquisition performed with the Trinity® Perine probe, at the end of the BOOST implant insertion procedure
Measured: 24 hours
Secondary outcomes (11)
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires
Assessment of toxicity by questionnaires (IPSS score + urinary symptom quality of life).
IPSS:: International Prostate Score Symptom (0 to 35: Score 20-35: severely symptomatic. Score 8-19: moderately symptomatic)
Measured: 12 months
Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry
Assessment of toxicity by urinary flowmetry
Measured: 12 months
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score
Assessment of toxicity by classification of toxicities according to CTCAE score (Common Terminology Criteria for Adverse Events: Grade 1 Mild / Grade 2 Moderate / Grade 3 Severe or medically significant but not immediately life-threatening / Grade 4 Life-threatening consequences / Grade 5 Death related to A
Measured: 12 months
To assess the efficacy of the treatment at M6 and M12.
PSA (Prostate Specific Antigen) test
Measured: 12 months
To check the absence of overdose in the prostate at D0 and M1.
V150% < 60% of prostate volume on CT dosimetry at D0 and 1 month
Measured: 1 month
To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.
Absence of overdose in organs at risk on scanner dosimetry
Measured: 1 month
Dose to CTV-dosi at 150%
V150% > 95% for CTV-dosi (on Variseed dosimetry) at J0
Measured: 1 month
Assess quality of life (inclusion, M1, M3, M6, M12).
QLQ-C30 (Quality of Life Questionnaire) score
Measured: 12 months
Assess sexual health (inclusion, M1, M3, M6, M12).
IIEF5 questionnaire score (Erectile dysfunction severe (score 5-10), moderate (11-15), mild (16-20), normal erectile function (21-25) and uninterpretable (1-4)).
Measured: 12 months
Measure the duration of the complete procedure, the additional act (BOOST) and the final ultrasound acquisition performed at the end of the procedure (when performed).
Duration of the entire procedure, the additional procedure (BOOST), and the final ultrasound acquisition at the end of the procedure (when performed)
Measured: 24 hours
(For the last 5 patients): Estimate the quality of the registration after insertion of the implants.
(For the last 5 patients): Final ultrasound acquisition performed at the end of the procedure with the Trinity® Perine system
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start4 Apr 2023
- Primary completion25 Jul 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Koelis
- Responsible party
- Sponsor
- Investigators
- Carole Iriard, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322356
- Sponsor's protocol ID
- 2021-A01178-33
- Acronym
- FOCUS-BOOST
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D Ultrasound System
- ClinicalTrials.gov ID
- NCT05322356
- Acronym / sponsor ID
- FOCUS-BOOST / 2021-A01178-33
- Conditions
- Prostate Cancer
- Keywords
- Interstitial brachytherapy, Iodine 125 implant, 3D TRINITY® Perine system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Koelis
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Apr 2022 (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.
The objective of the FOCUS-Boost project is to implant for the first time with a 3D ultrasound image fusion registration system (3D echo) implant of iodine 125 with precision in a target volume determined by positive biopsies.
Detailed description
The interstitial brachytherapy procedure for the prostate does not allow for a robust focal treatment to accurately deliver additional dose to the tumour volume. FOCUS BOOST allows the precise implantation of 125 iodine implant with greater accuracy (using a 3D ultrasound image fusion registration system) in a target volume.
For this purpose, positive biopsies, performed in this research protocol, will be used prior to surgery. Prostate brachytherapy will be optimised thanks to the TRINITY® system and its guidance quality, by increasing the dose of the intra-prostate tumour volume (BOOST) without increasing the total dose delivered to the prostate. Increasing the dose to the tumour target volume could improve disease control and decrease the risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3DInterstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years
- Patient to be treated with brachytherapy
- Patient with low or favorable intermediate risk prostate adenocarcinoma ISUP 1 and 2, G6 (3+3) or G7 (3+4)
- Life expectancy of more than 10 years
- PSA (prostate-specific antigen) < 15 ng/ml
Key exclusion criteria (10 listed)
- Patient with urinary function disorders IPSS> 14
- Prostate volume > 60cc.
- Gleason 7(4+3) or Gleason score ≥8
- PSA ≥ 15 ng/ml
- Patient with metastases
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 |
|---|---|---|
| Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3DTarget dose supplement with the TRINITY® PERINE 3D system | Other | Intervention |
Primary outcome
Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies.
Time frame: 24 hours
To evaluate the number of successful/failed iodine 125 implants (BOOST implants) implanted in the CTV-boost (Clinical Target Volume) defined from the mapping of positive biopsies. The maximum number of BOOST implant implanted will be 4 implants, depending on the size of the target: 10 mm< target ≤ 15 mm = 2 implants; 15 mm < target ≤ 20mm = 3 implants; 20 mm < target ≤ 30 mm = 4 implants; Success is defined as "the centre of the implant is in the target volume". Failure is defined as "the centre of the implant is outside the target volume". The primary endpoint is evaluated on the ultrasound acquisition performed with the Trinity® Perine probe, at the end of the BOOST implant insertion procedure
11 secondary outcomes
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12), with questionnaires
Time frame: 12 months
Assess toxicity (pre brachytherapy visit, M1, M12) with flowmetry
Time frame: 12 months
Assess toxicity (pre brachytherapy visit, M1, M3, M6, M12) with CTCAE score
Time frame: 12 months
To assess the efficacy of the treatment at M6 and M12.
Time frame: 12 months
To check the absence of overdose in the prostate at D0 and M1.
Time frame: 1 month
To check the absence of overdose in organs at risk (bladder, urethra, rectum) at D0 and M1.
Time frame: 1 month
Dose to CTV-dosi at 150%
Time frame: 1 month
Assess quality of life (inclusion, M1, M3, M6, M12).
Time frame: 12 months
Assess sexual health (inclusion, M1, M3, M6, M12).
Time frame: 12 months
Measure the duration of the complete procedure, the additional act (BOOST) and the final ultrasound acquisition performed at the end of the procedure (when performed).
Time frame: 24 hours
(For the last 5 patients): Estimate the quality of the registration after insertion of the implants.
Time frame: 24 hours
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 1 May 2026.
- Centre d'Investigation Clinique Innovation TechnologiqueLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Carole Iriard, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interstitial Brachytherapy of the Prostate With Iodine 125 Implant With Target Dose Supplementation in the Tumor Volume Guided by the TRINITY® PERINE 3D in people with Prostate Cancer, run by University Hospital, Grenoble at 1 site in France.
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 10 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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 France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant for the first time, in a clinical situation, iodine 125 implants in a planned target volume, using a 3D echo-mapping fusion guidance system of positive biopsies. (time frame: 24 hours). 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 1 May 2026.