Single Fraction Early Prostate Irradiation (SiFEPI) (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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: exclusive single-fraction irradiation	Radiation: exclusive single-fraction irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute urinary toxicity occurring within 6 months after irradiation.	to assess the acute urinary toxicity occurring within 6 months after irradiation.	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute digestive toxicity occurring during the 6 months following irradiation	Assessment of acute digestive toxicity occurring during the 6 months following irradiation,	up to 5 years

Other Outcome Measures

Outcome Measure	Time Frame
Local recurrence-free survival at 5 years	up to 5 years

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2013-A01514-41; 2013/16 (Other Identifier: Centre Antoine Lacassagne)