Prostate CancerSiFEPINCT02104362
Single Fraction Early Prostate Irradiation (SiFEPI)
A study testing exclusive single-fraction irradiation in people with Prostate Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- exclusive single-fraction irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to 14 Jun 2021
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from histologically-proven adenocarcinoma-type prostate cancer:
- with low risk of biochemical recurrence
- with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)*
- stage T1c, T2a, T2b
- Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies
- PSA < 15 ng/ml
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- Age ≥ 18 years
- Karnofsky index ≥ 70%
- Life expectancy ≥ 10 years
- No contraindication to injection of hyaluronic acid in the prostate-rectal interspace
- Patient aware of the information leaflet and having signed the informed consent form
- Patient covered by medical insurance
Who cannot join
- Stage ≥ T2c
- Gleason score 7 (4+3) or ≥ 8
- PSA > 15 ng/ml
- Presence of the following anatomico-pathological criteria:
- Involvement of the nerve fibers
- Peri-tumoral vascular embolisms
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- Capsule involvement
- Number of positive biopsies ≥ 50%
- 100% positive biopsies in a lobe
- Involvement of the seminal vesicle
- Prostate volume ≥60 cc
- Large prostatic transurethral resection and/or dating from less than 6 months
- Poor urinary function in the absence of alpha-blockers
- IPSS score > 15
- Post-mictional residue > 50 cc
- Flow rate with Qmax < 12 ml/s
- Remote metastasis
- Neoadjuvant anti-androgenic treatment
- Prior treatment with pelvic irradiation and/or chemotherapy
- Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment
- History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years
- Evolving psychiatric disorder
- Vulnerable persons as defined by article L1121-5 to -8
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade > 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.
The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy.
The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction.
Read the detailed description
Expected benefit(s) of the trial
- Improved quality of life during brachytherapy on account of the absence of radioactive seeds in the prostate:
- Fewer early urinary complications,
- No urine filtration,
- No post-operative use of condoms,
- No 2-year ban on cremation following treatment,
- Health cost savings,
- Acquisition of dosimetric data for inverse optimization.
Predictable risk(s) for patients Predictable risks in the context of this trial involve the frequency of essentially urinary disorders.
Methodology Open, monocentric, phase I-II study.
- Conditions
- Prostate Cancer
- Being tested
- exclusive single-fraction irradiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exclusive single-fraction irradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| exclusive single-fraction irradiation | Other | Not described Receives: Radiation: exclusive single-fraction irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute urinary toxicity occurring within 6 months after irradiation.
to assess the acute urinary toxicity occurring within 6 months after irradiation.
Measured: up to 5 years
Secondary outcomes (1)
acute digestive toxicity occurring during the 6 months following irradiation
Assessment of acute digestive toxicity occurring during the 6 months following irradiation,
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completion13 Nov 2017
- Study completion14 Jun 2021
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 Prostate CancerStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104362
- Sponsor's protocol ID
- 2013-A01514-41
- Other IDs
- 2013/16
- Acronym
- SiFEPI
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2014
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hannoun-Levi JM, Chand-Fouche ME, Pace-Loscos T, Gautier M, Gal J, Schiappa R, Pujol N. Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial. Clin Transl Radiat Oncol. 2022 Aug 18;37:64-70. doi: 10.1016/j.ctro.2022.08.007. eCollection 2022 Nov.
PubMed 36093342
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence
- ClinicalTrials.gov ID
- NCT02104362
- Acronym / sponsor ID
- SiFEPI / 2013-A01514-41
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 4 Apr 2014 (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.
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade > 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.
The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy.
The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction.
Detailed description
Expected benefit(s) of the trial
- Improved quality of life during brachytherapy on account of the absence of radioactive seeds in the prostate:
- Fewer early urinary complications,
- No urine filtration,
- No post-operative use of condoms,
- No 2-year ban on cremation following treatment,
- Health cost savings,
- Acquisition of dosimetric data for inverse optimization.
Predictable risk(s) for patients Predictable risks in the context of this trial involve the frequency of essentially urinary disorders.
Methodology Open, monocentric, phase I-II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exclusive single-fraction irradiation | Other | Radiation: exclusive single-fraction irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients suffering from histologically-proven adenocarcinoma-type prostate cancer:
- PSA < 15 ng/ml
- Age ≥ 18 years
- Karnofsky index ≥ 70%
- Life expectancy ≥ 10 years
Key exclusion criteria (23 listed)
- Stage ≥ T2c
- Gleason score 7 (4+3) or ≥ 8
- PSA > 15 ng/ml
- Presence of the following anatomico-pathological criteria:
- Prostate volume ≥60 cc
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 |
|---|---|---|
| exclusive single-fraction irradiation | Radiation | exclusive single-fraction irradiation |
Primary outcome
acute urinary toxicity occurring within 6 months after irradiation.
Time frame: up to 5 years
to assess the acute urinary toxicity occurring within 6 months after irradiation.
1 secondary outcome
acute digestive toxicity occurring during the 6 months following irradiation
Time frame: up to 5 years
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 23 Apr 2026.
- Results publication: PubMed 36093342Hannoun-Levi JM, Chand-Fouche ME, Pace-Loscos T, Gautier M, Gal J, Schiappa R, Pujol N. Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial. Clin Transl Radiat Oncol. 2022 Aug 18;37:64-70. doi: 10.1016/j.ctro.2022.08.007. eCollection 2022 Nov.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exclusive single-fraction irradiation in people with Prostate Cancer, run by Centre Antoine Lacassagne 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 12 inclusion and 23 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 23 Apr 2026. 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?
acute urinary toxicity occurring within 6 months after irradiation. (time frame: up to 5 years). 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 NCT02104362, 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 23 Apr 2026.