Patient case: 72-year-old male with Cholangiocarcinoma. Genetic variant: BRCA2. Other conditions: Diabetes.

Clinical trial: Single Fraction Early Prostate Irradiation (SiFEPI)

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.

Eligibility: 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

Relevance to patient case: not relevant