NCT02104362

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
RADIATION	exclusive single-fraction irradiation

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-11-13
• Completion: 2021-06-14
• First posted: 2014-04-04
• Last updated: 2021-10-06

Locations

1 site across 1 country: France