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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

A single-arm, open-label Phase II clinical trial to evaluate the effect of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GenSpera, Inc.

Criteria

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.