Two-Fraction High Dose Rate Brachytherapy Delivered Three Hours Apart for Localized Prostate Cancer

Inclusion Criteria

• Participants must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
• National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b – cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Karnofsky > 60%)
• Eligible to undergo HDR brachytherapy as monotherapy as determined by the treating radiation oncologist
• Ability to understand and the willingness to sign a written informed consent document
• Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. Routine screening for HIV status and viral count will not be performed for this study, as there are no specific concerns regarding this study, delivery of radiotherapy with brachytherapy and HIV. If a participant has a history of being positive for HIV, their medical records will be reviewed to determine their viral count status and degree of immunocompromised status, and further referrals may be sought if no recent (< 6 months) documentation regarding their HIV is available to better assess their overall health and ability to undergo HDR brachytherapy
• For participants with a history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Routine screening for HBV will not be performed for this study. If a participant has a history of chronic HBV infection, their medical records will be reviewed to determine if their viral load is undetectable and on suppressive therapy, if indicated. If there are concerns regarding their chronic HBV infection, further referrals may be sought if no recent (< 6 months) documentation regarding their HBV status are available
• Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Routine screening for HCV will not be performed for this study. If a participant has a history of HCV, their medical records will be reviewed to determine if they have been treated and cured. If there are concerns regarding their HCV status, further referrals may be sought
• Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Willingness and ability to complete International Prostate Symptom Score questionnaires

Exclusion Criteria

• Any prior treatment for prostate cancer
• Prior history of pelvic malignancy
• Any prior androgen deprivation therapy
• Is currently receiving any other investigational agents
• Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure
• Contraindications to general anesthesia
• Contraindications to radiotherapy
• Prior history of pelvic radiotherapy
• Presence of lymph node or distant metastases
• Prior cryosurgery or cryotherapy to the prostate
• Prior transurethral resection of the prostate (TURP) or transurethral incision within the previous 6 months
• Estimated prostate volume >60 cubic centimeters as determined by transrectal ultrasound or magnetic resonance imaging
• International Prostate Symptom Score (IPSS) score of 15 or higher prior to treatment