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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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