Localized Prostate CancerPhase 2CURIEFOCALENCT01902680
Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
A Phase 2 study testing Focal brachytherapy in people with Localized Prostate Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up). The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- Focal brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2013to 6 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Men of more than 18 years old
- Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
- Lesion classified T1c or T2a based on digital rectal exam
- histologically proven diagnosis of prostatic adenocarcinoma with a Gleason score ≤ 6
- Serum Prostatic Specific Antigen (PSA) <10ng/ml
- Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
Show all 16Show fewer
- Patient with good micturating function at inclusion, defined by IPSS score <10 (IPSS Questionnaire)
- Patient for whom the result of centralized PSA assay confirms a serum level < 10ng/ml
- Patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal MRI imaging (ESUR Score ≥ 9) and whose major axis has a size ≤ 20 mm
- Patient with a Gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using KOELIS ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
- Patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
- Patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
- WHO ≤ 2
- Patient with life expectancy > 10 years
- Informed consent obtained and signed before any specific procedure in the study
- Patient affiliated to social security regimen
Who cannot join
- Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
- Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
- Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
- Patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry MRI) or a significant dysuria (IPSS ≥ 10)
Show all 13Show fewer
- Patient unable to follow procedures, visits, examinations described in the the study
- Patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
- Man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
- Any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
- Any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
- Any coexisting medical condition that in the opinion of the investigator could be a risk in this study
- Patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).
The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
- Conditions
- Localized Prostate Cancer
- Being tested
- Focal brachytherapy
- Keywords
- Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal brachytherapyRadiation
Focal brachytherapy with permanent I125 localized implant.
| Study group | Role | What they receive |
|---|---|---|
| Focal brachytherapy | Experimental | Focal brachytherapy with permanent I125 localized implant. Receives: Radiation: Focal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
Measured: 3 years
Secondary outcomes (4)
Progression-free-survival according to Phoenix criterion
Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion
Measured: 3 years
Quality of life study using 3 Patient questionnaires
Quality of life will be evaluated using 3 Patient questionnaires : the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire, the International Index of Erectile Function Questionnaire and the International Prostate Symptom Score Questionnaire
Measured: 3 years
Absence of tumor residuals in the target treated zone
The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation
Measured: 3 years
Toxicity evaluation
Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study start23 Aug 2013
- Primary completion7 Jul 2016
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Localized Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902680
- Sponsor's protocol ID
- 12 URO 06
- Acronym
- CURIEFOCALE
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2013
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Graff P, Portalez D, Lusque A, Brun T, Aziza R, Khalifa J, Roumiguie M, Quintyn Ranty ML, Filleron T, Bachaud JM, Malavaud B. IDEAL 2a Phase II Study of Ultrafocal Brachytherapy for Low- and Intermediate-risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 15;102(4):903-911. doi: 10.1016/j.ijrobp.2018.01.066. Epub 2018 Feb 2.
PubMed 29510957
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
- ClinicalTrials.gov ID
- NCT01902680
- Acronym / sponsor ID
- CURIEFOCALE / 12 URO 06
- Conditions
- Localized Prostate Cancer
- Keywords
- Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 23 Aug 2013 (actual)
- Primary completion
- 7 Jul 2016 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 18 Jul 2013 (estimated)
- 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 is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).
The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal brachytherapy | Experimental | Radiation: Focal brachytherapyFocal brachytherapy with permanent I125 localized implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men of more than 18 years old
- Patient with localized prostate cancer with a good prognosis (AMICO classification), ie satisfying the following conditions according to the urologist medical record transmitted:
- Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
- Patient with good micturating function at inclusion, defined by IPSS score <10 (IPSS Questionnaire)
- Patient for whom the result of centralized PSA assay confirms a serum level < 10ng/ml
Key exclusion criteria (13 listed)
- Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
- Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
- Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
- Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
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 |
|---|---|---|
| Focal brachytherapyFocal brachytherapy with permanent I125 localized implant. | Radiation | Focal brachytherapy |
Primary outcome
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation
Time frame: 3 years
Feasibility of focal therapy will be evaluated in terms of "success" or "failure" : success will be obtained in case of delivered dose of at least 152 Gy on the 1st dose enveloping the Planning Target Volume, evaluated on CT scan/MRI performed at Day 30
4 secondary outcomes
Progression-free-survival according to Phoenix criterion
Time frame: 3 years
Quality of life study using 3 Patient questionnaires
Time frame: 3 years
Absence of tumor residuals in the target treated zone
Time frame: 3 years
Toxicity evaluation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 29510957Graff P, Portalez D, Lusque A, Brun T, Aziza R, Khalifa J, Roumiguie M, Quintyn Ranty ML, Filleron T, Bachaud JM, Malavaud B. IDEAL 2a Phase II Study of Ultrafocal Brachytherapy for Low- and Intermediate-risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Nov 15;102(4):903-911. doi: 10.1016/j.ijrobp.2018.01.066. Epub 2018 Feb 2.
Related trials for Localized Prostate Cancer
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 2
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Focal brachytherapy in people with Localized Prostate Cancer, run by Institut Claudius Regaud 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 16 inclusion and 13 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: finished, as of the sponsor's last update on 14 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of focal therapy will be evaluated with dosimetric study by CT scan / MRI performed 30 days after implantation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902680, which also lists 1 linked publication.
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 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.