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

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ClinicalTrials.gov Identifier: NCT01902680
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief 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.


Condition or disease Intervention/treatment Phase
Localized Prostate Cancer Radiation: Focal brachytherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.
Actual Study Start Date : August 23, 2013
Actual Primary Completion Date : July 7, 2016
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Focal brachytherapy
Focal brachytherapy with permanent I125 localized implant.
Radiation: Focal brachytherapy
Focal brachytherapy with permanent I125 localized implant.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression-free-survival according to Phoenix criterion [ Time Frame: 3 years ]
    Progression-free-survival is defined as the time from patient inclusion to the date of biological progression according to Phoenix criterion

  2. Quality of life study using 3 Patient questionnaires [ Time Frame: 3 years ]
    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

  3. Absence of tumor residuals in the target treated zone [ Time Frame: 3 years ]
    The absence of tumor residuals in the target treated zone will be evaluated on on biopsies performed 1 year after implantation

  4. Toxicity evaluation [ Time Frame: 3 years ]
    Toxicity will be evaluated according to the classification of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902680


Locations
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France
Institut Claudius REGAUD
Toulouse, France, 31059
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01902680     History of Changes
Other Study ID Numbers: 12 URO 06
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Keywords provided by Institut Claudius Regaud:
Prostate cancer, permanent implant brachytherapy, image fusion, focal therapy, active surveillance

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases