Tiny implants take aim at prostate cancer: a smarter shot?
NCT ID NCT01902680
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 Hide 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
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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.
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