Low-Risk Prostate CancerFOSTINENCT03023345
Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
A study testing Microwave trans rectal focal treatment in people with Low-Risk Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration. Read more about this study
- Who is it for?
- Ages 45 to 76 years, men only
- Conditions the study is for
- Low-Risk Prostate Cancer
- What is being tested?
- Microwave trans rectal focal treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2017to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 76 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 45 to 76 years old ;
- Life expectancy above 10 years ;
- Diagnosis of prostate cancer confirmed on prostate biopsies ;
- Low risk of progression, defined with D'Amico criteria :
- T1c or T2a stage
- Maximum Gleason score of 3+4, including targeted biopsies corresponding to less than 50% grade 4 for the tumor
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- Prostate Specific Antigen <15 ng/mL
- Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ;
- Patient accepting to be followed after the procedure using active surveillance protocol standards ;
- Patient affiliated to national health care insurance ;
- Free consent, informed and written, dated and signed by the patient and the investigator before enrollment.
Who cannot join
- Medical past history of prostatic surgery ;
- Medical past history of radiotherapy or pelvic trauma ;
- Medical past history of acute or chronic prostatitis
- severe BPH-related urinary tract symptoms defined as an IPSS >18 ;
- Extra-capsular extension or seminal vesicle invasion on prostate MRI.
- Tumor involvement > 3 mm on systematic biopsies outside the tumor volume detected on MRI.
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- Tumor largest axis > 20 mm on prostate MRI ;
- Distance of less than 5 mm between the tumor and the rectum
- Patient unable to understand the course of the study
- History of allergy or non-tolerance to gadolinium salts used in MRI
- Patient with a contraindication to performing an MRI
- Person placed under safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.
Read the detailed description
In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.
The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).
- Conditions
- Low-Risk Prostate Cancer
- Being tested
- Microwave trans rectal focal treatment
- Keywords
- cancer, prostate, PSA, biopsies, microwave trans rectal focal treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave trans rectal focal treatmentDevice
Also called Microwave thermal ablation system called TATO (Biomedical)
Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
| Study group | Role | What they receive |
|---|---|---|
| Microwave | Experimental | Microwave trans rectal focal treatment Receives: Device: Microwave trans rectal focal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete necrosis of the index tumor on prostate MRI
Measured: 7 days
Secondary outcomes (10)
Margins of necrosis around the index tumor on prostate MRI
Measured: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Measured: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Measured: 1 month
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Measured: 3 months
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Measured: 6 months
Urinary symptoms using IPSS
to assess urinary tolerance
Measured: 7 days
Urinary symptoms using IPSS
to assess urinary tolerance
Measured: 1 month
Urinary symptoms using IPSS
to assess urinary tolerance
Measured: 3 months
Urinary symptoms using IPSS
to assess urinary tolerance
Measured: 6 months
Number of cancer on targeted biopsies within the treated volume
to assess oncological efficacy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start12 Sep 2017
- Primary completion5 Nov 2018
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-Risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Unité de Recherche Clinique Necker Cochin, Fr
- Responsible party
- Sponsor
- Investigators
- Nicolas BARRY DELONGCHAMPS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023345
- Sponsor's protocol ID
- P160301
- Acronym
- FOSTINE
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2017
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.
PubMed 34260598
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03023345
- Acronym / sponsor ID
- FOSTINE / P160301
- Conditions
- Low-Risk Prostate Cancer
- Keywords
- cancer, prostate, PSA, biopsies, microwave trans rectal focal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Unité de Recherche Clinique Necker Cochin, Fr
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.
Detailed description
In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.
The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave | Experimental | Device: Microwave trans rectal focal treatmentMicrowave trans rectal focal treatment |
Who may qualify
- Ages
- 45 to 76 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged from 45 to 76 years old ;
- Life expectancy above 10 years ;
- Diagnosis of prostate cancer confirmed on prostate biopsies ;
- Low risk of progression, defined with D'Amico criteria :
- Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ;
Key exclusion criteria (12 listed)
- Medical past history of prostatic surgery ;
- Medical past history of radiotherapy or pelvic trauma ;
- Medical past history of acute or chronic prostatitis
- severe BPH-related urinary tract symptoms defined as an IPSS >18 ;
- Extra-capsular extension or seminal vesicle invasion on prostate MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave trans rectal focal treatmentAlso: Microwave thermal ablation system called TATO (Biomedical)Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration | Device | Microwave |
Primary outcome
Complete necrosis of the index tumor on prostate MRI
Time frame: 7 days
10 secondary outcomes
Margins of necrosis around the index tumor on prostate MRI
Time frame: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Time frame: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Time frame: 1 month
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Time frame: 3 months
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
Time frame: 6 months
Urinary symptoms using IPSS
Time frame: 7 days
Urinary symptoms using IPSS
Time frame: 1 month
Urinary symptoms using IPSS
Time frame: 3 months
Urinary symptoms using IPSS
Time frame: 6 months
Number of cancer on targeted biopsies within the treated volume
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 34260598Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas BARRY DELONGCHAMPS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave trans rectal focal treatment in people with Low-Risk Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete necrosis of the index tumor on prostate MRI (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.