ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023
Phase I Study of Niraparib in Combination with Radium-223 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Novel Therapeutic Strategies for Metastatic Prostate Cancer Care.European urology · 2025Pooled it
- Tumor‑immune spatiotemporal co‑evolution: A new paradigm for understanding and overcoming therapy resistance in metastatic castration‑resistant prostate cancer (Review).International journal of molecular medicine · 2026Review
- Novel hormone therapies for advanced prostate cancer: Understanding and countering drug resistance.Journal of pharmaceutical analysis · 2025Review
- Changing metastatic patterns associate with dynamics of circulating tumor DNA in metastatic castration-resistant prostate cancer.The oncologist · 2025Article
- The Tight Relationship Between the Tumoral Microenvironment and Radium-223.Biomedicines · 2025Review
- Bibliometric analysis of research trends on the combination of radiotherapy and PARP inhibitors in solid tumors.Frontiers in pharmacology · 2025Review
- The Landscape of PARP Inhibitors in Solid Cancers.OncoTargets and therapy · 2025Review
- Targeted and immunotherapeutic strategies for castration-resistant prostate cancer: emerging strategies, challenges, and future directions.Frontiers in immunology · 2025Review
- TAM Plasticity under androgen deprivation therapy and PARP inhibition in prostate cancer: a multi-omics perspective.Frontiers in immunology · 2025Review
- PARP inhibitors in prostate cancer: clinical applications.Molecular biology reports · 2024Review
- DNA Damage by Radiopharmaceuticals and Mechanisms of Cellular Repair.Pharmaceutics · 2023Review
- New insights into molecular signaling pathways and current advancements in prostate cancer diagnostics & therapeutics.Frontiers in oncology · 2023Review
- PARP inhibitors in metastatic prostate cancer.Frontiers in oncology · 2023Review
- PARP inhibitors alone or in combination for prostate cancer.Therapeutic advances in urologyReview
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
purposeTo identify the safety of niraparib, a PARP inhibitor, in combination with Radium-223 for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) in men without known BRCA mutations. PATIENTS AND
methodsMen with progressive mCPRC following ≥1 line of androgen receptor (AR)-targeted therapy and bone metastases but no documented BRCA-1 or BRCA-2 alterations or bulky visceral disease were included. Niraparib dose was escalated in combination with standard dosing of Radium-223 using a time-to-event continual reassessment method. The highest dose level with a DLT probability <20% was defined as MTD. Secondary endpoints included PSA change and progression-free survival. Exploratory analyses included assessing DNA mutations found in ctDNA as well as gene expression changes assessed in whole blood samples.
resultsThirty patients were treated with niraparib and radium-223: 13 patients received 100 mg, 12 received 200 mg, and 5 patients received 300 mg of niraparib. There were six DLT events: two (13%) for neutropenia, two (13%) for thrombocytopenia, whereas fatigue and nausea each occurred once (3%). Anemia (2/13%) and neutropenia (2/13%) were the most common grade 3 adverse events. For patients with prior chemotherapy exposure, the MTD was 100 mg, whereas the MTD for chemotherapy naïve patients was 200 mg. Whole blood gene expression of PAX5 and CD19 was higher in responders and ARG-1, IL2R, and FLT3 expression was higher in nonresponders.
conclusionsCombining niraparib with Radium-223 in patients with mCRPC was safe; however, further studies incorporating biomarkers will better elucidate the role of combinations of PARP inhibitors with DNA damaging and other agents.
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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.