Single Fraction Early Prostate Irradiation (SiFEPI)
SiFEPI
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
2 other identifiers
interventional
35
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Feb 2014
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedApril 23, 2026
April 1, 2026
3.8 years
March 31, 2014
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
acute urinary toxicity occurring within 6 months after irradiation.
to assess the acute urinary toxicity occurring within 6 months after irradiation.
up to 5 years
Secondary Outcomes (1)
acute digestive toxicity occurring during the 6 months following irradiation
up to 5 years
Other Outcomes (1)
Local recurrence-free survival at 5 years
up to 5 years
Study Arms (1)
exclusive single-fraction irradiation
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- Capsule involvement
- Number of positive biopsies ≥ 50%
- % 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Antoine Lacassagne
Nice, 06000, France
Related Publications (1)
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.
PMID: 36093342RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 4, 2014
Study Start
February 1, 2014
Primary Completion
November 13, 2017
Study Completion
June 14, 2021
Last Updated
April 23, 2026
Record last verified: 2026-04