ArticlePloS one2023
A phase I clinical trial of oncolytic adenovirus mediated suicide and interleukin-12 gene therapy in patients with recurrent localized prostate adenocarcinoma.
Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02555397 (Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy), which is not on this map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic and Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer After Definitive Radiotherapy
Who cites it
18 citing papers in PubMed.
- A Phase II Study of Docetaxel and Pembrolizumab plus Interleukin 12 Gene Therapy in Nonmetastatic, Anthracycline-Refractory Triple-Negative Breast Cancer (INTEGRAL).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Stem Cell-Delivered Cytosine Deaminase/5-Fluorocytosine and TRAIL Gene Therapy for Castration-Resistant Prostate Cancer: Translational Synthesis and First-in-Human Trial Concept.International journal of molecular sciences · 2026Review
- Bridging mechanism and clinic: unlocking the full potential of oncolytic virus-based immunotherapy.Molecular cancer · 2026Review
- Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review.Molecular therapy. Advances · 2026Review
- CAR-T Cell Therapy for Prostate Cancer: Current Advances and Future Perspectives.Biomedicines · 2025Review
- Synergistic targeting strategies for prostate cancer.Nature reviews. Urology · 2025Review
- Four decades of adenovirus gene transfer vectors: History and current use.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Pancreatic Cancer: Pathogenesis and Clinical Studies.MedComm · 2025Review
- Potentiating intratumoral therapy with immune checkpoint inhibitors: shifting the paradigm of multimodality therapeutics.Immuno-oncology technology · 2025Review
- Tumor microbiome: roles in tumor initiation, progression, and therapy.Molecular biomedicine · 2025Review
- Unraveling the anti-inflammatory effects of Mediterranean diet in patients with cancer remission.Frontiers in immunology · 2025Article
- Experimental models for developing oncolytic virotherapy for metastatic prostate cancer.Frontiers in immunology · 2025Review
- An Engineered Self-biomineralized Oncolytic Adenovirus Induces Effective Antitumor Immunity and Synergizes With Immune Checkpoint Blockade.Cancer immunology research · 2024Article
- Expression of Interleukin-8, Interleukin-12 and Interleukin-13 in Esophageal Squamous Cell Carcinoma: Biomarker Potentiality and Prognostic Significance.Journal of gastrointestinal cancer · 2024Article
- Harnessing adenovirus in cancer immunotherapy: evoking cellular immunity and targeting delivery in cell-specific manner.Biomarker research · 2024Review
- Innovative strategies in genitourinary cancer: the role of oncolytic viruses.Frontiers in oncology · 2024Review
- Progression of oncolytic virus in liver cancer treatment.Frontiers in oncology · 2024Review
- The power of mumps virus: Matrix protein activates apoptotic pathways in human colorectal cell lines.PloS one · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
In a phase I dose escalation and safety study (NCT02555397), a replication-competent oncolytic adenovirus expressing yCD, TK and hIL-12 (Ad5-yCD/mutTKSR39rep-hIL-12) was administered in 15 subjects with localized recurrent prostate cancer (T1c-T2) at increasing doses (1 × 1010, to 1 × 1012 viral particles) followed by 7-day treatment of 5-fluorocytosine (5-FC) and valganciclovir (vGCV). The primary endpoint was toxicity through day 30 while the secondary and exploratory endpoints were quantitation of IL-12, IFNγ, CXCL10 and peripheral blood mononuclear cells (PBMC). The study maximum tolerated dose (MTD) was not reached indicating 1012 viral particles was safe. Total 115 adverse events were observed, most of which (92%) were grade 1/2 that did not require any treatment. Adenoviral DNA was detected only in two patients. Increase in IL-12, IFNγ, and CXCL10 was observed in 57%, 93%, and 79% patients, respectively. Serum cytokines demonstrated viral dose dependency, especially apparent in the highest-dose cohorts. PBMC analysis revealed immune system activation after gene therapy in cohort 5. The PSA doubling time (PSADT) pre and post treatment has a median of 1.55 years vs 1.18 years. This trial confirmed that replication-competent Ad5-IL-12 adenovirus (Ad5-yCD/mutTKSR39rep-hIL-12) was well tolerated when administered locally to prostate tumors.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.