Guided Biopsy for Mapping Prostate Cancer (HIT)

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Prostatectomy Read More

Inclusion Criteria:

• Patients must have histologically confirmed diagnosis of prostate cancer
• Patients must have elected to undergo radical prostatectomy using an open, laparoscopic or robotic approach
• Patients must be at least 18 years of age and able to provide written informed consent.
• No history of radiotherapy, chemotherapy or hormone therapy within 6 months of surgery
• Primary tumor must be amenable to surgical removal for curative intent
• Patients must have ECOG-performance status 0 or 1 (appendix II)
• Patients must have no history of rectal or anal disease.

• Patients must have adequate organ function as defined by the following criteria:

  • Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT])≤2.5x local laboratory upper limit of normal (ULN), or AST and ALT ≤5x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin ≤1.5 x ULN
  • Absolute neutrophil count(ANC)≥1,500/microL
  • Platelets≥lOO,OOO/microL
  • Hemoglobin≥9.0 g/dL
  • Serum calcium≤10.2mg/dL (correct for low albumin if necessary; calcium + (normal albumin - serum albumin)x 0.8)
  • Patients must have serum creatinine<2 mg/dL or serum creatinine clearance (CrCl)>40ml/min(CrCl= Wt(kg)x(140-age)*/72xCr. level,*female x 0.85)

Inclusion of minorities:

• Members of all races and ethnic groups are eligible for this trial. Women and children are not eligible since prostate cancer is not diagnosed in these groups.