Single Fraction Early Prostate Irradiation (SiFEPI)

Sponsor
Centre Antoine Lacassagne (Other)
Overall Status
Completed
CT.gov ID
NCT02104362
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
88.4
Actual Duration (Months)
0.4
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
N/A

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:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Nov 13, 2017
Actual Study Completion Date :
Jun 14, 2021

Arms and Interventions

ArmIntervention/Treatment
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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Centre Antoine LacassagneNiceFrance06000

Sponsors and Collaborators

  • Centre Antoine Lacassagne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT02104362
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