Trial reportProstate cancer and prostatic diseases2021
Proof-of-principle Phase I results of combining nivolumab with brachytherapy and external beam radiation therapy for Grade Group 5 prostate cancer: safety, feasibility, and exploratory analysis.
Trial report in Prostate cancer and prostatic diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03543189 (Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy in the Management of Gleason Group 5 Prostate Cancer), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.
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.
Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy in the Management of Gleason Group 5 Prostate Cancer
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Pooled it
- Immunotherapy in urological cancers: new paradigms and a systematic review of clinical trials and real-world evidence.Frontiers in oncology · 2026Pooled it
- Efficacy and safety of immune checkpoint inhibitors for patients with prostate cancer: a systematic review and meta-analysis.Frontiers in immunology · 2023Pooled it
- Phase II trial of combination radiation, hormone, and immunotherapy in grade group 5 prostate cancer.Journal for immunotherapy of cancer · 2026Trial
- Article
- Synergistic potential and challenges of immunotherapy combined with radiotherapy in metastatic castration-resistant prostate cancer: a review of mechanisms and clinical advances.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Brachytherapy: Perspectives for combined treatments with immunotherapy.Clinical and translational radiation oncology · 2025Review
- The application of emerging immunotherapy in the treatment of prostate cancer: progress, dilemma and promise.Frontiers in immunology · 2025Review
- The role of immunotherapy in targeting tumor microenvironment in genitourinary cancers.Frontiers in immunology · 2025Review
- Ultrasound-guided percutaneous radiofrequency ablation combined with anti-PD-1 for the treatment of prostate cancer: an experimental study.Frontiers in oncology · 2025Article
- Immunological facets of prostate cancer and the potential of immune checkpoint inhibition in disease management.Theranostics · 2024Review
- Radioimmunotherapy: a game-changer for advanced non-small cell lung cancer.Frontiers in immunology · 2024Review
- Review
- Radiotherapy combined with nano-biomaterials for cancer radio-immunotherapy.Journal of nanobiotechnology · 2023Review
- Radiotherapy plus immune checkpoint inhibitor in prostate cancer.Frontiers in oncology · 2023Review
- Boosting the Immune Response-Combining Local and Immune Therapy for Prostate Cancer Treatment.Cells · 2022Review
- Radiotherapy combined with immunotherapy: the dawn of cancer treatment.Signal transduction and targeted therapy · 2022Review
- Lattice or Oxygen-Guided Radiotherapy: What If They Converge? Possible Future Directions in the Era of Immunotherapy.Cancers · 2021Review
- The roles of PD-1/PD-L1 in the prognosis and immunotherapy of prostate cancer.Molecular therapy : the journal of the American Society of Gene Therapy · 2021Review
- Interaction Between Modern Radiotherapy and Immunotherapy for Metastatic Prostate Cancer.Frontiers in oncology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 1 institution in 1 country.
Funding
Abstract
backgroundTo determine whether combining brachytherapy with immunotherapy is safe in prostate cancer (PCa) and provides synergistic effects, we performed a Phase I/II trial on the feasibility, safety, and benefit of concurrent delivery of anti-PD-1 (nivolumab) with high-dose-rate (HDR) brachytherapy and androgen deprivation therapy (ADT) in patients with Grade Group 5 (GG5) PCa.
methodsEligible patients were aged 18 years or older with diagnosis of GG5 PCa. Patients received ADT, nivolumab every two weeks for four cycles, with two cycles prior to first HDR, and two more cycles prior to second HDR, followed by external beam radiotherapy. The primary endpoint was to determine safety and feasibility. This Phase I/II trial is registered with ClinicalTrials.gov (NCT03543189).
resultsBetween September 2018 and June 2019, six patients were enrolled for the Phase I safety lead-in with a minimum observation period of 3 months after nivolumab administration. Overall, nivolumab was well tolerated in combination with ADT and HDR treatment. One patient experienced a grade 3 dose-limiting toxicity (elevated Alanine aminotransferase and Aspartate aminotransferase) after the second cycle of nivolumab. Three patients (50%) demonstrated early response with no residual tumor detected in ≥4 of 6 cores on biopsy post-nivolumab (4 cycles) and 1-month post-HDR. Increase in CD8+ and FOXP3+/CD4+ T cells in tissues, and CD4+ effector T cells in peripheral blood were observed in early responders.
conclusionCombination of nivolumab with ADT and HDR is well tolerated and associated with evidence of increased immune infiltration and antitumor activity.
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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.