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Single Fraction Early Prostate Irradiation (SiFEPI) (SiFEPI)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exclusive single-fraction irradiation
Sponsored by
Centre Antoine Lacassagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Centre Antoine Lacassagne

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

exclusive single-fraction irradiation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2014
Last Updated
October 5, 2021
Sponsor
Centre Antoine Lacassagne
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1. Study Identification

Unique Protocol Identification Number
NCT02104362
Brief Title
Single Fraction Early Prostate Irradiation (SiFEPI)
Acronym
SiFEPI
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
June 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
exclusive single-fraction irradiation
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
exclusive single-fraction irradiation
Primary Outcome Measure Information:
Title
acute urinary toxicity occurring within 6 months after irradiation.
Description
to assess the acute urinary toxicity occurring within 6 months after irradiation.
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
acute digestive toxicity occurring during the 6 months following irradiation
Description
Assessment of acute digestive toxicity occurring during the 6 months following irradiation,
Time Frame
up to 5 years
Other Pre-specified Outcome Measures:
Title
Local recurrence-free survival at 5 years
Time Frame
up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.centreantoinelacassagne.org
Description
Related Info

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Single Fraction Early Prostate Irradiation (SiFEPI)

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