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 or 7 (3+4 or 4+3). Subjects will be candidates for definitive therapy.
Subjects will receive up to four (4) TRUS-guided intratumoral treatments with Ad5-SGE-REIC/Dkk-3 into the prostate approximately 6-weeks apart. Each treatment cycle will be performed using three track injections through the prostrate using 1 mL each injection (3 mL total) with focus on the most dense areas of cancer based on biopsy mapping.
Subjects will be considered a success if they experience a 50% drop in PSA or a 1 point drop in the Gleason score after 24 weeks. Subjects who are progressing at any time after the second injection of Ad5-SGE-REIC/Dkk-3 will be discontinued and will be treated according to standard medical practice.