Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

Korábbi kezelés

• Preregistration GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy
• Patients receiving any other investigational agents.
• Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT

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• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements.

• Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer.
  • Biopsy must be performed within 182 days of trial registration
  • Biopsy should be a standard sextant biopsy AND either a targeted MR/ultrasound guided biopsy or saturation biopsy or both.
• Initial cancer diagnosis that fits these specific criteria:
  • Stages T1-T3a
  • Nx or N0
  • Mx or M0
• Eligible initial definitive radiotherapy modalities include:
• External beam radiotherapy, with photon or proton beam therapy
  • Conventional or moderately hypofractionated radiotherapy
  • Extremely hypofractionated external beam radiotherapy (Stereotactic body radiation therapy)
• Definitive Brachytherapy:
  • Low-dose rate
  • High-dose rate
• Locally recurrent disease confined to the prostate +/- seminal vesicles and immediately adjacent tissue, as evaluated by the following:
  • History/Physical examination
  • Radiographically node negative disease (N0), as defined by CT or MR of pelvis +/- abdomen within 6 months of registration.
  • No evidence of bone metastases (M0) on bone scan within 6 months of registration.
  • Fluciclovine-PET is encouraged, but not required
• Patients receiving ADT are eligible as long as they meet the other eligibility criteria. However, the duration of all ADT must be documented.
• Current ECOG Performance status Scale 0-2
• Current International Prostate Symptom Score (IPSS) \< 20
• The patient must be medically suitable to receive general anesthesia.
• The patient must be able and willing to sign a study-specific written informed consent form before study entry.