Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Localized Prostate Cancer

In brief

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

Key facts

Study ID

NCT01931046

Run by

Momotaro-Gene Inc.

People needed

28

Starts

2013-10-01

Expected to finish

2020-03-01

Last updated by the study team

2020-09-04

Who can join

Age: 50 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Key Inclusion Criteria:
• Subjects must meet all of the following criteria to be included:
• Male aged between 50 and 80 years (inclusive) with histologically documented clinically localized, adenocarcinoma of the prostate.
• Subject with clinical stage T1 or T2 with Gleason score of 6 or 7 (3+4 or 4+3).
• At least one (1) MRI evaluable tumor with volume of 400 mm3 or greater.
• At least total of 10 mm of cancer tissue based on an MRI guided 12-core biopsy.
• Recent (≤ 6 months prior to study entry) negative bone scan and computerized tomography (CT) scan of abdomen/pelvis.
• Life expectancy of at least 5 years.
• Subjects should have adequate bone marrow function defined as an absolute peripheral granulocyte count ≥ 1,500 and platelet count of ≥ 100,000, adequate hepatic function with a bilirubin ≤ 1.5 mg/dl and serum glutamic-pyruvic transaminase (SGPT) < 4x the upper limits of normal, adequate renal function defined as serum creatinine ≤ 2.0 mg/dl
• Subjects must have a coagulation profile (prothrombin time [PT], partial thromboplastin time [PTT]) not more than 2-times the upper limit of normal and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants within 5-days of the Ad5-SGE-REIC/Dkk-3 injections is limited to local use only (for control of central line patency).
• Subject is willing to refrain from sexual activity or agrees to use a barrier contraceptive device (e.g. condom) for 8-weeks after treatment with Ad5-SGE-REIC/Dkk-3.
• Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
• Key Exclusion Criteria
• Subjects meeting any of the following criteria will be excluded:
• Prior primary radiation treatment to the prostate.
• Severe bladder outlet obstructive disorder (AUA >25) or urinary track retention.
• Chemotherapy, immunotherapy or other investigational study drug within the past 4 weeks.
• Unable to tolerate TRUS.
• Subjects with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorders, that in the opinion of the investigator put the subject at significant risk, are not eligible.
• Subjects who are HIV positive or have active hepatitis B or C infections are not eligible.
• Subjects with a clinical history of primary or secondary immunodeficiency, autoimmune disease or subjects taking immunosuppressive drugs such as corticosteroids continuously for > 4 months [> 5 mg hydrocortisone/day] are ineligible.
• As a result of medical review, physical examination, the Principal Investigator (or medically qualified nominee) considers the subject unfit for the study.

Where it is running

• UCSD Moores Cancer Center — San Diego, California, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• The Methodist Hospital Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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