Single Fraction Early Prostate Irradiation (SiFEPI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Antoine Lacassagne
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT02104362
First received: March 31, 2014
Last updated: April 3, 2014
Last verified: April 2014

March 31, 2014
April 3, 2014
February 2014
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02104362 on ClinicalTrials.gov Archive Site
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,
Same as current
Local recurrence-free survival at 3 years [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Same as current
 
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Radiation: exclusive single-fraction irradiation
exclusive single-fraction irradiation
Intervention: Radiation: exclusive single-fraction irradiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
July 2019
June 2016   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
France
 
NCT02104362
2013-A01514-41, 2013/16
Yes
Centre Antoine Lacassagne
Centre Antoine Lacassagne
Not Provided
Not Provided
Centre Antoine Lacassagne
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP