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Feasibility of Neoadjuvant Ad-REIC Gene Therapy in Patients with High-Risk Localized Prostate Cancer Undergoing
Hiromi Kumon1, Katsumi Sasaki1, Yuichi Ariyoshi1
1Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Abstract:
In a phase I/IIa study of in situ gene therapy using an adenovirus vector carrying the human REIC/Dkk-3 gene (Ad-REIC), we assessed the inhibitory effects of cancer recurrence after radical prostatectomy (RP), in patients with high risk localized prostate cancer (PCa). After completing the therapeutic interventions with initially planned three escalating doses of 1.0 × 10(10) , 1.0 × 10(11) , and 1.0 × 10(12) viral particles (VP) in 1.0-1.2 mL (n = 3, 3, and 6), an additional higher dose of 3.0 × 10(12) VP in 3.6 mL (n = 6) was further studied. Patients with recurrence probability of 35% or more within 5 years after RP as calculated by Kattan's nomogram, were enrolled. They received two ultrasound-guided intratumoral injections at 2-week intervals, followed by RP 6 weeks after the second injection. Based on the findings of MRI and biopsy mapping, as a rule, one track injection to the most prominent cancer area was given to initial 12 patients and 3 track injections to multiple cancer areas in additional 6 patients. As compared to the former group, biochemical recurrence-free survival of the latter showed a significantly favorable outcome. Neoadjuvant Ad-REIC, mediating simultaneous induction of cancer selective apoptosis and augmentation of antitumor immunity, is a feasible approach in preventing cancer recurrence after RP. (199).
Insights
Neoadjuvant Ad-REIC gene therapy shows promise in preventing prostate cancer recurrence after surgery. Multiple injections targeting cancer areas improved outcomes, suggesting a feasible approach to enhance antitumor immunity.
Area of Science:
- Oncology
- Gene Therapy
- Urology
Background:
- Radical prostatectomy (RP) is a standard treatment for localized prostate cancer (PCa).
- High-risk PCa patients face a significant probability of cancer recurrence post-RP.
- Novel therapeutic strategies are needed to prevent recurrence and improve patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of neoadjuvant in situ gene therapy using Ad-REIC (adenovirus vector carrying the human REIC/Dkk-3 gene).
- To assess the potential of Ad-REIC in inhibiting cancer recurrence after RP in high-risk PCa patients.
- To explore the safety and feasibility of escalating doses and injection strategies of Ad-REIC.
Main Methods:
- Phase I/IIa study involving high-risk localized PCa patients scheduled for RP.
- Patients received escalating doses of Ad-REIC via ultrasound-guided intratumoral injections before RP.
- Injection strategies varied (single vs. multiple tracks) based on MRI and biopsy findings.
Main Results:
- Neoadjuvant Ad-REIC therapy was administered at doses up to 3.0 × 10(12) viral particles.
- Patients receiving multiple track injections demonstrated significantly better biochemical recurrence-free survival compared to single-track injections.
- The treatment mediated cancer-selective apoptosis and augmented antitumor immunity.
Conclusions:
- Neoadjuvant Ad-REIC gene therapy is a feasible approach for preventing prostate cancer recurrence post-RP.
- Multiple injection tracks targeting diverse cancer areas appear more effective than single-track injections.
- Ad-REIC holds potential for inducing apoptosis and enhancing anti-tumor immune responses.
