Single Fraction Early Prostate Irradiation (SiFEPI) (SiFEPI)
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.
Radiation: exclusive single-fraction irradiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- acute urinary toxicity occurring within 6 months after irradiation. [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]to assess the acute urinary toxicity occurring within 6 months after irradiation.
- acute digestive toxicity occurring during the 6 months following irradiation [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Assessment of acute digestive toxicity occurring during the 6 months following irradiation,
- Local recurrence-free survival at 3 years [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|exclusive single-fraction irradiation||Radiation: exclusive single-fraction irradiation|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02104362
|Centre Antoine Lacassagne||Recruiting|
|Nice, France, 06000|
|Contact: Jean-Michel HANNOUN LEVI, Phd +33 4 92 03 12 71 firstname.lastname@example.org|
|Principal Investigator: Jean-Michel HANNOUN LEVI, Phd|