Hypofractionated Stereotactic Boost in Prostate Cancer

Intermediate-risk Prostate Cancer : Assessment of Hypofractionated Stereotactic Boost - Prospective Phase II Study

hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

The aim of this study is to assess the safety of hypofractionated stereotactic boost radiation (prostate) after normofractionated radiotherapy (prostate + seminal vesicles).

Inclusion Criteria:

• Prostate adenocarcinoma proved by histology

• With at least one of this intermediate-risk criterias:

  • T2b
  • and/or PSA between 10 et 20 ng/ml
  • and/or Gleason score = 7

• Prostatic volume ≤ 80 cc

• No adenopathy(lymph node < 1.5 cm on scanner or MRI and/or in lymph node dissection)

• No metastasis (bone scan)

• Age >= 18 ans

• No prior pelvic irradiation

• No prior anticancer treatment (prostatectomy, chemotherapy, hormonotherapy > 3 months)

• Performance status (ECOG) < 1

• No contraindication of fiducials implantation, hemostasis disorders must be treated before the implantation

• Life expectancy >= 10 weeks

• Patient affiliated to health insurance

• Informed consent signed by the patient

Exclusion Criteria:

• Cancer no histologically proved
• Unfavorable-risk(T2c and/or PSA > 20 ng/ml and/or Gleason > 7)
• Favorable-risk(T1c T2a and PSA < 10 ng/ml and Gleason < 7)
• T3 and T4
• History of cancer uncontrolled and/or treated since less of 5 years (except basal cell carcinoma of the skin)
• Contraindication to MRI
• IPSS score > 10
• Recurrent or metastatic disease
• Allergy to gold
• Patient already included in another therapeutic trial with an experimental molecule
• Unable for medical follow-up (geographic, social or mental reasons)