Single Fraction Early Prostate Irradiation (SiFEPI) (SiFEPI)
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|ClinicalTrials.gov Identifier: NCT02104362|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2014
Last Update Posted : July 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: exclusive single-fraction irradiation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||November 13, 2017|
|Estimated Study Completion Date :||November 13, 2020|
|exclusive single-fraction irradiation||
Radiation: exclusive single-fraction irradiation
- acute urinary toxicity occurring within 6 months after irradiation. [ Time Frame: up to 5 years ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104362
|Centre Antoine Lacassagne|
|Nice, France, 06000|