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Ongoing Clinical Trials

Please contact Christine Kent, RN, CCRC, NE-BC, (832) 325-6515, or email christine.m.kent@uth.tmc.edu for details about the trials below.

Hormonal Therapy and Chemotherapy Followed by Prostatectomy in Patients with Prostate Cancer

This study assesses the safety and benefit of androgen-deprivation therapy (ADT) plus chemotherapy before prostate removal. Participants will be treated with four weeks of ADT, accompanied by 16 weeks of chemotherapy. At week 18-19, they will undergo radical prostatectomy. The study is open to men who have locally advanced prostate cancer and are eligible to undergo prostatectomy.

Lead Physician: Robert J. Amato, D.O.

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

This single-arm phase II clinical trial is evaluating the effect of G-202, a prodrug activated in prostate cancer tissue and in the blood vessels of tumors – but not in normal tissue. G-202 is expected to bring about cell death in prostate cancer cells and destroy the blood supply of prostate tumors. The treatment has led to disease stabilization in some patients but has not been evaluated previously in the neoadjuvant setting.

Lead Physician: Robert J. Amato, D.O.

Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer

Men who have prostate cancer and have failed local therapy or are not candidates for prostatectomy or radiation therapy may be eligible for this study, which assesses the safety and benefit of androgen-deprivation therapy (ADT) to block hormones, plus chemotherapy. The current standard treatment is ADT and chemotherapy; what differs in this clinical trial is the cycling and combination of chemotherapy drugs selected, which have fewer side effects and are believed to provide maximum benefit.

Lead Physician: Robert J. Amato, D.O.

Apalutamide Plus Intermittent Hormone Therapy (IHT) versus IHT Alone in Prostate Cancer Patients with Biochemical Recurrence

Apalutamide is a synthetic compound designed to bind the androgen receptor, prevent both nuclear translocation and DNA binding, and induce apoptosis. It has greater anti-tumor activity at a lower dose, achieves steady-state levels at a lower dose and accumulates in tumor tissue without building up in the brain, which increases effectiveness and decreases the risk of seizure associated with other androgen-receptor inhibitors. This trial will determine how much longer apalutamide plus 3-month depot leuprolide controls PSA to levels <1 ng/dL compared with 3-month depot leuprolide alone.

Lead Physician: Robert J. Amato, D.O.

Phase III Study of DCVAC Added to Standard Chemotherapy for Men with Metastatic Castration-resistant Prostate Cancer (VIABLE)

DCVAC/PCa therapy is an immunotherapy created from the patient’s own cells, designed to increase the tumor-killing effect of standard-of-care chemotherapy by stimulating immune response. Participants in this trial receive CVAC/PCa consisting of dendritic cells produced from their own blood samples and standard-of-care chemotherapy with ocetaxel plus prednisone.

Lead Physician: Robert J. Amato, D.O.

Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance (Transformer)

This study is specifically designed for patients who present with asymptomatic metastatic castration-resistant prostate cancer who were previously treated with abiraterone. Participants will be randomized to receive either enzalutamide or intramuscular testosterone given on a dose and schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near-castrate levels of testosterone.

Lead Physician: Robert J. Amato, D.O.

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Overexpressing, Triple-negative Breast Cancer (METRIC)

The researchers’ primary goal is to assess the anti-cancer activity of CDX-011 in metastatic GPNMB over-expressing, triplenegative breast cancer. CDX-011 is an antibody-drug conjugate, combining a tumor-targeting antibody with a cytotoxic agent. Patients enrolled in the study will receive the CDX-011 as an IV infusion every three weeks until disease progression.

Lead Physician: Anneliese Gonzalez, M.D.

A Phase III, Randomized, Openlabel, Multicenter, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane) plus Carboplatin in Subjects with Squamous Cell Non-small Cell Lung Cancer (NSCLC)

This study assesses whether nab-Paclitaxel is an effective maintenance agent against squamous cell non-small cell lung cancer after first-line therapy. For the induction portion of the study, patients receive the FDA-approved agents nabpaclitaxel and carboplatin as IV infusions. Carboplatin will be given once every 21 days, and the nab-paclitaxel will be given weekly for a total of four 21-day cycles. After assessment for disease status, patients who have benefited from the induction portion of the study will be enrolled in the maintenance study where they will receive nab-paclitaxel for the first two weeks of the three-week cycle until it is determined the treatment is no longer effective.

Lead Physician: Syed Jafri, M.D.