Phase I Trial of High Dose Rate Brachytherapy Combined With Stereotactic Body Radiation Therapy for Intermediate Risk Prostate Cancer Patients
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
• Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
• To rule out metastatic disease, patients must have the following tests:
‣ Bone scan within 60 days prior to registration
⁃ Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration
• Karnofsky performance status \> 70
• Age \> 18
• PSA blood test within 60 days prior to registration
• Prostate biopsy within 180 days prior to registration
• Within 60 days prior to registration, hematologic minimal values:
‣ Absolute neutrophil count \> 1,500/mm\^3
⁃ Hemoglobin \> 8.0 g/dl
⁃ Platelet count \> 100,000/mm\^3
• Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
• No history of previous pelvic irradiation