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
  Purpose

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 Intervention Phase
Breast Cancer
Radiation: exclusive single-fraction irradiation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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,


Other Outcome Measures:
  • Local recurrence-free survival at 3 years [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: February 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
exclusive single-fraction irradiation 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104362

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06000
Contact: Jean-Michel HANNOUN LEVI, Phd    +33 4 92 03 12 71    jean-michel.hannoun-levi@nice.unicancer.fr   
Principal Investigator: Jean-Michel HANNOUN LEVI, Phd         
Sponsors and Collaborators
Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT02104362     History of Changes
Other Study ID Numbers: 2013-A01514-41, 2013/16
Study First Received: March 31, 2014
Last Updated: April 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014