High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
NCT04945642
Summary
This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Eligibility
Inclusion Criteria: * Ability to understand a written informed consent document, and the willingness to sign it * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration * Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7 * No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis) * Prostate size =\< 60cc * International Prognostic Scoring System (IPSS) score =\< 15 * Able to safely receive moderate sedation or general anesthesia Exclusion Criteria: * Patients with neuroendocrine or small cell carcinoma of the prostate * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years * Regional lymph node involvement * Evidence of distant metastases * Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer * Previous pelvic irradiation or prostate brachytherapy * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major bowel surgery * Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment
Conditions9
Locations1 site
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NCT04945642