G-202 in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Prostate Cancer

Inclusion Criteria: * ECOG Performance Status \< 2 * Histological confirmation of prostatic adenocarcinoma that is confined to the prostate without evidence of regional and/or distant metastasis * Clinical stage T1c or T2a with high-grade disease (Gleason 8-10) on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical stage T3 * Negative bone scan and CT of chest and abdomen within 6 weeks of first infusion of G-202 * Candidate for radical prostatectomy * Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mm3) * Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin \< 2 mg/dL) * Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN) * Acceptable coagulation profile (no history of substantial non-iatrogenic bleeding diatheses, INR ≤ 2.3, aPTT ≤ 1.5 x ULN) * Ejection fraction (LVEF) ≥ 45% measured by echocardiogram * Willing to use acceptable methods of contraception to avoid pregnancy Exclusion Criteria: * Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features * Unable to tolerate mpMRI * Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week prior to first G-202 treatment * Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy, or other investigational status drug for prostatic adenocarcinoma * Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents * Use of anti-coagulants is limited to local use for control of central line patency * History or evidence of cardiac risk * Uncontrolled cardiac or coronary artery disease * Uncontrolled hypertension or hypertension requiring treatment with more than 2 anti-hypertensive agents * Severe or uncontrolled medical disease * Severe gastrointestinal bleeding within 12 weeks prior to treatment with G-202 * Known history of HIV, hepatitis B or hepatitis C * Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids * Documentation of keratosis follicularis * Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes * Another primary malignancy, except non-melanoma skin cancer, that has not been in remission for at least 2 years.