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

NCT01902680 | Completed Phase 2

• 1 other identifier: 12 URO 06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer

Keywords

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

Outcome Measures

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

  3 years

Secondary Outcomes (4)

• Progression-free-survival according to Phoenix criterion

  3 years

• Quality of life study using 3 Patient questionnaires

  3 years

• Absence of tumor residuals in the target treated zone

  3 years

• Toxicity evaluation

  3 years

Study Arms (1)

Focal brachytherapy

EXPERIMENTAL

Focal brachytherapy with permanent I125 localized implant.

Radiation: Focal brachytherapy

Interventions

Focal brachytherapy RADIATION

Focal brachytherapy with permanent I125 localized implant.

Focal brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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 coexisting medical condition that in the opinion of the investigator could be a risk in this study
• Patient protected by law

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius REGAUD

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 29510957 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 18, 2013
• Study Start: August 23, 2013
• Primary Completion: July 7, 2016
• Study Completion: June 6, 2017
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)