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High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

RecruitingNA

Sponsor: Jonsson Comprehensive Cancer Center

Conditions: Prostate Adenocarcinoma, Stage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8

Interventions: High-Dose Rate Brachytherapy, Stereotactic Body Radiation Therapy

Countries: United States

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Los Angeles, California, United States