Single Fraction Early Prostate Irradiation (SiFEPI)

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.

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