NCT02381236

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

G-202-005: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 Administered in the Neoadjuvant Setting Followed by Radical Prostatectomy in Patients With Adenocarcinoma of the Prostate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GenSpera, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

More than one-third of patients with localized high-risk prostate cancer who undergo radical prostatectomy eventually relapse with distant disease and some data suggest that neoadjuvant treatment in this patient population may be helpful. This study is based on prodrug tumor targeting, in which an inactive form of a toxic agent is administered systemically and gets activated in specific locations in the body, resulting in higher concentrations of the cytotoxic form at the tumor location. G-202 is a prodrug that is activated in prostate cancer tissue and in the blood vessels of tumors, but not normal tissue; once activated, G-202 leads to disruption of intracellular calcium levels and subsequent induction of apoptosis. Thus, G-202 is expected to bring about cell death in prostate cancer cells and to destroy the blood supply of prostate tumors. G-202 has led to disease stabilization in some patients, but the drug has not been evaluated in the neoadjuvant setting. This single-arm, open-label Phase II clinical trial will evaluate the safety and activity of G-202 in patients with localized high-risk prostate cancer prior to radical prostatectomy. Through its effects on the neovasculature of tumors, G-202 is anticipated to disrupt the blood supply of the prostate tumor, resulting in decreased perfusion and subsequent tumor volume. The primary endpoint of this study is evaluation of G-202 on the perfusion and volume of the prostate using non-invasive multiparametric prostate magnetic resonance imaging (mpMRI).

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	G-202	G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle for up to 3 cycles

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2015-03-06
• Last updated: 2017-02-24

Locations

1 site across 1 country: United States