Single Fraction Early Prostate Irradiation (SiFEPI) (NCT02104362) | Clinical Trial Compass
CompletedNot Applicable
Single Fraction Early Prostate Irradiation (SiFEPI)
France35 participantsStarted 2014-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Histo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
acute urinary toxicity occurring within 6 months after irradiation.