Single Fraction Early Prostate Irradiation (SiFEPI)

Centre Antoine Lacassagne35 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

acute urinary toxicity occurring within 6 months after irradiation.

to assess the acute urinary toxicity occurring within 6 months after irradiation.

Time frame: up to 5 years

Secondary Outcomes

acute digestive toxicity occurring during the 6 months following irradiation

Assessment of acute digestive toxicity occurring during the 6 months following irradiation,