Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer


Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02739659

Sponsor: Shanghai Proton and Heavy Ion Center

Eligibility:

  • Age: minimum 20 Years maximum 85 Years
  • Gender: Male

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the prostate
  • No lymph node and distant metastasis
  • Age ≥ 20 and < 85 years of age
  • Karnofsky Performance Score ≥70
  • No previous pelvic radiation therapy (RT)
  • No previous prostatectomy
  • No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
  • Ability to understand character and individual consequences of the clinical trial
  • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

  • No pathologically confirmed adenocarcinoma of the prostate
  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Urinary obstructive symptoms (IPSS > 20)
  • Previous pelvic radiotherapy
  • Previous prostatectomy
  • Severe systemic disorders
  • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
  • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
  • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
  • Psychiatric disorders or any other condition that can make unreliable the informed consent

View trial on ClinicalTrials.gov


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