Single Fraction Early Prostate Irradiation (SiFEPI)

Centre Antoine Lacassagne (Other)
Overall Status
Completed ID
Actual Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: exclusive single-fraction irradiation

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.

Study Design

Study Type:
Actual Enrollment :
35 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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 :
Feb 1, 2014
Actual Primary Completion Date :
Nov 13, 2017
Actual Study Completion Date :
Jun 14, 2021

Arms and Interventions

Other: exclusive single-fraction irradiation

Radiation: exclusive single-fraction irradiation

Outcome Measures

Primary Outcome Measures

  1. acute urinary toxicity occurring within 6 months after irradiation. [up to 5 years]

    to assess the acute urinary toxicity occurring within 6 months after irradiation.

Secondary Outcome Measures

  1. acute digestive toxicity occurring during the 6 months following irradiation [up to 5 years]

    Assessment of acute digestive toxicity occurring during the 6 months following irradiation,

Other Outcome Measures

  1. Local recurrence-free survival at 5 years [up to 5 years]

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


SiteCityStateCountryPostal Code
1Centre Antoine LacassagneNiceFrance06000

Sponsors and Collaborators

  • Centre Antoine Lacassagne


None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:


None provided.
Responsible Party:
Centre Antoine Lacassagne Identifier:
Other Study ID Numbers:
  • 2013-A01514-41
  • 2013/16
First Posted:
Apr 4, 2014
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021