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CompletedNCT01902680CURIEFOCALEUpdated Apr 14, 2026

Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.

A Phase 2 interventional study of Focal brachytherapy in Localized Prostate Cancer, sponsored by Institut Claudius Regaud. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Institut Claudius Regaud · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
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Study 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 of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.

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Conditions studied

  • Localized Prostate Cancer

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Keywords

  • Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 18 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Men of more than 18 years old
  2. 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
  3. Patient for whom the Multidisciplinary Consultative Meeting (RCP) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
  4. Patient with good micturating function at inclusion, defined by IPSS score \<10 (IPSS Questionnaire)
  5. Patient for whom the result of centralized PSA assay confirms a serum level \< 10ng/ml
  6. 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
  7. 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
  8. Patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
  9. 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
  10. WHO ≤ 2
  11. Patient with life expectancy > 10 years
  12. Informed consent obtained and signed before any specific procedure in the study
  13. Patient affiliated to social security regimen

Exclusion criteria

Exclusion Criteria:

  1. Image in favour of the crossing of the capsule, based on pre-implantation multimodal MRI (stage T2 MRI only)
  2. Image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal MRI (stage T2 MRI only)
  3. Multifocal lesions (ESUR ≥ 9/15) to the pre-implantation multimodal MRI and for which biopsies have shown the cancerous nature
  4. Lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal MRI
  5. Patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
  6. 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)
  7. Patient unable to follow procedures, visits, examinations described in the the study
  8. Patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
  9. 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
  10. 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
  11. Any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
  12. Any coexisting medical condition that in the opinion of the investigator could be a risk in this study
  13. Patient protected by law
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Focal brachytherapy

    Focal brachytherapy with permanent I125 localized implant.

    Radiation: Focal brachytherapy

Interventions

  • RadiationFocal brachytherapy

    Focal brachytherapy with permanent I125 localized implant.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 3 years

  2. 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

    Time frame: 3 years

  3. 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

    Time frame: 3 years

  4. Toxicity evaluation

    Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0

    Time frame: 3 years

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Study locations

1 site
  • Institut Claudius REGAUD
    Toulouse, 31059, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01902680
Lead sponsor
Institut Claudius Regaud
Responsible party
Sponsor
First posted
Jul 18, 2013
Start date
Aug 23, 2013
Primary completion
Jul 7, 2016
Completion
Jun 6, 2017
Last update
Apr 14, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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