NCT01931046

Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

A Phase 1 / 2a Study of In-situ REIC/Dkk-3 Therapy in Patients With Localized Prostate Cancer (MTG-REIC-PC003)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Momotaro-Gene Inc. · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.

Detailed description

This is a phase 1/2a clinical trial in subjects who are diagnosed with prostate cancer to evaluate the effectiveness of Ad5-SGE-REIC/Dkk-3 in the treatment of localized prostate cancer. Subjects enrolled will be diagnosed with localized prostate cancer (clinical stage T1/T2) having a Gleason score of 6 to 7 (3+4 or 4+3). Subjects will receive up to four (4) transrectal ultrasound (TRUS)-guided IT treatments with Ad5-SGE-REIC/Dkk-3 into the prostate approximately 6-weeks apart. Each treatment cycle will be performed using a minimum of three track injections through the prostrate using a total of 3 mL volume. Approximately 2 mL of the total volume will be injected into the most dense areas of cancer based on biopsy and MRI mapping (fusion biopsy) and 1 mL total volume will be injected into the opposite lobe of the prostate or other areas to ensure complete saturation of the prostate over multiple injections. Subjects who, in the opinion of the investigator, are progressing at any time after the second injection of Ad5-SGE-REIC/Dkk-3 may be discontinued and will be treated according to standard medical practice.

Conditions

• Localized Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ad5-SGE-REIC/Dkk3	Ad5-SGE-REIC/Dkk-3, was designed to increase intracellular production REIC protein. The adenovirus vector is a transport mechanism to infuse the REIC protein into the cell providing a temporary transfusion of protein that induces apoptosis in target cancer cells, but does not appear to have a significant effect on normal tissues.

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-07-06
• Completion: 2020-03-01
• First posted: 2013-08-29
• Last updated: 2020-09-04

Locations

3 sites across 1 country: United States