Single Fraction Early Prostate Irradiation (SiFEPI)

NCT ID: NCT02104362

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2021-06-14

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exclusive single-fraction irradiation

Group Type: OTHER

exclusive single-fraction irradiation

Intervention Type: RADIATION

Interventions

exclusive single-fraction irradiation

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Related Links

http://www.centreantoinelacassagne.org

Related Info

Other Identifiers

2013/16

Identifier Type: OTHER

Identifier Source: secondary_id

2013-A01514-41

Identifier Type: -

Identifier Source: org_study_id