Clinical trial · Interventional
Single Fraction Early Prostate Irradiation (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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exclusive single-fraction irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- exclusive single-fraction irradiation
- interventionNames
- Radiation: exclusive single-fraction irradiation
Primary outcomes (1)
- measure
- acute urinary toxicity occurring within 6 months after irradiation.
- timeFrame
- up to 5 years
- description
- to assess the acute urinary toxicity occurring within 6 months after irradiation.
Secondary outcomes (1)
- measure
- acute digestive toxicity occurring during the 6 months following irradiation
- timeFrame
- up to 5 years
- description
- Assessment of acute digestive toxicity occurring during the 6 months following irradiation,
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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% * 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
References
Publications (1)
- RESULTHannoun-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 36093342