A phase II randomized trial of metastasis-directed therapy with alpha emitter radium-223 in men with oligometastatic castration-resistant prostate cancer (MEDAL).
Soichiro YoshidaTaro TakaharaYuki AritaMasaya ItoSara HayakawaTomohiko OguchiYoshinobu KomaiNoboru NumaoTakeshi YuasaMasaharu InoueHiroki UshijimaShigehiro KudoYasumasa ShimanoYuki NakamuraYusuke UchidaSho UeharaHajime TanakaHiroshi YaegashiKouji IzumiMinato YokoyamaYoh MatsuokaYasuo YoshiokaKoji KonishiKatsuyuki NakanishiAkira NagaharaAkihiro HirakawaRyuji KoikeFumitaka KogaKazuo NishimuraAtsushi MizokamiJunji YoneseYukio KageyamaRyoichi YoshimuraYasuhisa FujiiPublished in: BMC urology (2023)
This will be the first randomized trial to evaluate the effect of radium-223 in combination with targeted therapy in oligometastatic CRPC patients. The combination of targeted therapy for macroscopic metastases with radiopharmaceuticals targeting micrometastasis is expected to be a promising new therapeutic strategy for patients with oligometastatic CRPC confined to bone. Trial registration Japan Registry of Clinical Trials (jRCT) (jRCTs031200358); Registered on March 1, 2021, https://jrct.niph.go.jp/latest-detail/jRCTs031200358.
Keyphrases
- phase ii
- clinical trial
- open label
- phase iii
- end stage renal disease
- ejection fraction
- cancer therapy
- chronic kidney disease
- newly diagnosed
- double blind
- bone mineral density
- study protocol
- stem cells
- randomized controlled trial
- bone marrow
- placebo controlled
- patient reported outcomes
- mesenchymal stem cells
- cell therapy