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.