High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)
Jonsson Comprehensive Cancer Center
52 participants
Aug 20, 2021
INTERVENTIONAL
Conditions
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 Criteria9
- 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 Criteria9
- 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
Interventions
Undergo HDR-BT
Undergo SBRT
Locations(1)
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NCT04945642