Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01931046
Study type	Interventional
Source	Momotaro-Gene Inc.
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	October 2013
Completion date	March 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03996005` - MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer	N/A
Withdrawn	`NCT02159690` - A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy	Phase 2
Completed	`NCT00196781` - Treatment Decision Making in Early-Stage Prostate Cancer	Phase 3
Recruiting	`NCT03821246` - Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy	Phase 2
Active, not recruiting	`NCT03814252` - Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-TULSA for Localized Prostate Cancer	N/A
Completed	`NCT01714219` - Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy	N/A
Active, not recruiting	`NCT03315754` - Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.	Phase 2
Recruiting	`NCT05010343` - Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer	Phase 2
Recruiting	`NCT06325995` - Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer	N/A
Recruiting	`NCT06051942` - PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs	N/A
Completed	`NCT02297386` - [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer	Phase 1
Not yet recruiting	`NCT06117059` - The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance	N/A
Withdrawn	`NCT04225299` - Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer	Phase 3
Recruiting	`NCT06054867` - PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System	N/A
Active, not recruiting	`NCT02435472` - Active Surveillance Exercise Clinical Trial	N/A
Completed	`NCT00717613` - Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting	N/A
Completed	`NCT02662673` - Evaluation of Focal Treatments of Localized Prostate Cancers With High Intensity Focused Ultrasound Using the Focal One® Device	N/A
Recruiting	`NCT05155046` - 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy	Phase 2
Completed	`NCT01902680` - Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.	Phase 2
Recruiting	`NCT00651417` - Use of Organic Germanium or Placebo for the Prevention of Radiation Induced Fatigue	Phase 2