Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Tiny implants take aim at prostate cancer: a smarter shot?

NCT ID NCT01902680

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a precise radiation implant (brachytherapy) for men with low-risk prostate cancer. Instead of treating the whole prostate, doctors placed radioactive seeds only in the tumor area. The goal was to see if this targeted approach could deliver the right radiation dose safely. Only 18 men took part, and the study is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iodine-125 (I125) radioactive implant
What this could lead to
If successful, this could show that a targeted radiation implant can control low-risk prostate cancer with fewer side effects than whole-gland treatment.
What could go wrong
This is a very small, early-phase study with only 18 participants. It focuses on technical feasibility, not long-term cancer control or cure. The approach may not work for all patients or may miss cancer cells outside the targeted area.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Aug 2013

Finished

Jun 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Localized prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institut Claudius REGAUD

    Toulouse, 31059, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.