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

About This Trial

This study is testing a combination of two targeted radiation treatments: temporary internal radiation placed directly into the prostate and highly focused radiation beams aimed from outside the body.
Researchers want to see if using these precise methods together can safely destroy cancer cells in fewer visits while protecting nearby healthy organs.
The trial is open to adults with intermediate- or high-risk prostate cancer that has not spread to other parts of the body and who have not received prior prostate cancer treatments.
Before considering this study, patients should know that the internal radiation requires anesthesia and is not suitable for individuals with a history of inflammatory bowel disease or recent prostate surgery.

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.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is testing a combination of two targeted radiation treatments: temporary internal radiation placed directly into the prostate and highly focused radiation beams aimed from outside the body.

Full 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