Trial reportOncotarget2016
Samarium-153-EDTMP (Quadramet®) with or without vaccine in metastatic castration-resistant prostate cancer: A randomized Phase 2 trial.
Trial report in Oncotarget, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00450619 (A Randomized Phase 2.5 Study of), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Randomized Phase 2.5 Study of (153)Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Racial, ethnic, sex, and age representation in clinical trials of radiopharmaceutical tumor therapy: a systematic review and meta-analysis.BMC cancer · 2025Pooled it
- Combinations of treatments based on radiotherapy or radionuclides to enhance immunotherapy efficacy in advanced prostate cancer: a systematic review.Journal of cancer research and clinical oncology · 2025Pooled it
- Rare-Earth Elements at the Interface of Chemistry and Cancer Therapy.Molecules (Basel, Switzerland) · 2026Review
- The role of the tumor microenvironment in mediating radiopharmaceutical therapy: bridging nuclear medicine and cancer immunotherapy.Military Medical Research · 2026Review
- Invasion and metastasis in cancer: molecular insights and therapeutic targets.Signal transduction and targeted therapy · 2025Review
- Combination of Radioligand Therapy and Immunotherapy: How to Make It Work in Clinic?ImmunoTargets and therapy · 2025Article
- The application of emerging immunotherapy in the treatment of prostate cancer: progress, dilemma and promise.Frontiers in immunology · 2025Review
- Targeted Radiation and Immune Therapies-Advances and Opportunities for the Treatment of Prostate Cancer.Pharmaceutics · 2023Review
- Developments in Combining Targeted Radionuclide Therapies and Immunotherapies for Cancer Treatment.Pharmaceutics · 2022Review
- Review
- Combined with interventional therapy, immunotherapy can create a new outlook for tumor treatment.Quantitative imaging in medicine and surgery · 2021Review
- Interrogation of the cellular immunome of cancer patients with regard to the COVID-19 pandemic.Journal for immunotherapy of cancer · 2021Review
- Review
- Immune Analysis of Radium-223 in Patients With Metastatic Prostate Cancer.Clinical genitourinary cancer · 2018Article
- Targeting the Tumor Microenvironment with Immunotherapy for Genitourinary Malignancies.Current treatment options in oncology · 2018Review
- Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Immunotherapy of Prostate Cancer: Facts and Hopes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Review
- Cancer vaccines: Enhanced immunogenic modulation through therapeutic combinations.Human vaccines & immunotherapeutics · 2017Review
- Prostate cancer immunotherapy: the path forward.Current opinion in supportive and palliative care · 2017Review
- Optimizing tumor immune response through combination of radiation and immunotherapy.Medical oncology (Northwood, London, England) · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 1 country.
Funding
Abstract
PSA-TRICOM is a therapeutic vaccine in late stage clinical testing in metastatic castration-resistant prostate cancer (mCRPC). Samarium-153-ethylene diamine tetramethylene phosphonate (Sm-153-EDTMP; Quadramet®), a radiopharmaceutical, binds osteoblastic bone lesions and emits beta particles causing local tumor cell destruction. Preclinically, Sm-153-EDTMP alters tumor cell phenotype facilitating immune-mediated killing. This phase 2 multi-center trial randomized patients to Sm-153-EDTMP alone or with PSA-TRICOM vaccine. Eligibility required mCRPC, bone metastases, prior docetaxel and no visceral disease. The primary endpoint was the proportion of patients without radiographic disease progression at 4 months. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and immune responses. Forty-four patients enrolled. Eighteen and 21 patients were evaluable for the primary endpoint in Sm-153-EDTMP alone and combination arms, respectively. There was no statistical difference in the primary endpoint, with two of 18 (11.1%) and five of 21 (23.8%) in Sm-153-EDTMP alone and combination arms, respectively, having stable disease at approximately the 4-month evaluation time point (P = 0.27). Median PFS was 1.7 vs. 3.7 months in the Sm-153-EDTMP alone and combination arms (P = 0.041, HR = 0.51, P = 0.046). No patient in the Sm-153-EDTMP alone arm achieved prostate-specific antigen (PSA) decline > 30% compared with four patients (of 21) in the combination arm, including three with PSA decline > 50%. Toxicities were similar between arms and related to number of Sm-153-EDTMP doses administered. These results provide the rationale for clinical evaluation of new radiopharmaceuticals, such as Ra-223, in combination with PSA-TRICOM.
Indexed as
Identifiers
What OpenQuestion holds
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.