Evidence map›Paper›PMID 36879257›Full record

Trial reportBMC urology2023

A phase II randomized trial of metastasis-directed therapy with alpha emitter radium-223 in men with oligometastatic castration-resistant prostate cancer (MEDAL).

Soichiro Yoshida, Taro Takahara, Yuki Arita, Masaya Ito, Sara Hayakawa, Tomohiko Oguchi, Yoshinobu Komai, Noboru Numao, Takeshi Yuasa, Masaharu Inoue and 24 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 8 institutions in 1 country.

Soichiro YoshidaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan. s-yoshida.uro@tmd.ac.jp.ORCID http://orcid.org/0000-0003-2757-8083
Taro TakaharaDepartment of Biomedical Engineering, Tokai University School of Engineering, Kanagawa, Japan.
Yuki AritaDepartment of Radiology, Keio University School of Medicine, Tokyo, Japan.
Masaya ItoDepartment of Urology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Sara HayakawaDepartment of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Tomohiko OguchiDepartment of Genitourinary Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Yoshinobu KomaiDepartment of Genitourinary Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Noboru NumaoDepartment of Genitourinary Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Takeshi YuasaDepartment of Genitourinary Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Masaharu InoueDepartment of Urology, Saitama Cancer Center, Saitama, Japan.
Hiroki UshijimaDepartment of Radiation Oncology, Saitama Cancer Center, Saitama, Japan.
Shigehiro KudoDepartment of Radiation Oncology, Saitama Cancer Center, Saitama, Japan.
Yasumasa ShimanoDepartment of Radiation Oncology, Saitama Cancer Center, Saitama, Japan.
Yuki NakamuraDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Yusuke UchidaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Sho UeharaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Hajime TanakaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Hiroshi YaegashiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan.
Kouji IzumiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan.
Minato YokoyamaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Yoh MatsuokaDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Yasuo YoshiokaRadiation Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Koji KonishiDepartment of Radiation Oncology, Osaka International Cancer Institute, Osaka, Japan.
Katsuyuki NakanishiDepartment of Diagnostic and Interventional Radiology, Osaka International Cancer Institute, Osaka, Japan.
Akira NagaharaDepartment of Urology, Osaka International Cancer Institute, Osaka, Japan.
Akihiro HirakawaDepartment of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
Ryuji KoikeDepartment of Medical Innovation Promotion Center, Tokyo Medical and Dental University, Tokyo, Japan.
Fumitaka KogaDepartment of Urology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Kazuo NishimuraDepartment of Urology, Osaka International Cancer Institute, Osaka, Japan.
Atsushi MizokamiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Ishikawa, Japan.
Junji YoneseDepartment of Genitourinary Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Yukio KageyamaDepartment of Urology, Saitama Cancer Center, Saitama, Japan.
Ryoichi YoshimuraDepartment of Radiation Therapeutics and Oncology, Tokyo Medical and Dental University, Tokyo, Japan.
Yasuhisa FujiiDepartment of Urology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, 113-8510, Japan.
Tokyo Medical and Dental University · JPJapanese Foundation For Cancer Research · JPSaitama Cancer Center · JPOsaka International Cancer Institute · JPKanazawa University · JPTokyo Metropolitan Komagome Hospital · JPKeio University · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe significance of metastasis-directed therapy for oligometastatic prostate cancer has been widely discussed, and targeted therapy for progressive sites is a feasible option as a multidisciplinary treatment for castration-resistant prostate cancer (CRPC). When oligometastatic CRPC with only bone metastases progresses after targeted therapy, it tends to progress as multiple bone metastases. The progression of oligometastatic CRPC after targeted therapy may be due in part to the presence of micrometastatic lesions that, though undetected on imaging, were present prior to targeted therapy. Thus the systemic treatment of micrometastases in combination with targeted therapy for progressive sites is expected to enhance the therapeutic effect. Radium-223 dichloride (radium-223) is a radiopharmaceutical that selectively binds to sites of increased bone turnover and inhibits the growth of adjacent tumor cells by emitting alpha rays. Therefore, for oligometastatic CRPC with only bone metastases, radium-223 may enhance the therapeutic effect of radiotherapy for active metastases.

methodsThis phase II, randomized trial of Metastasis-Directed therapy with ALpha emitter radium-223 in men with oligometastatic CRPC (MEDAL) is designed to assess the utility of radium-223 in combination with metastasis-directed radiotherapy in patients with oligometastatic CRPC confined to bone. In this trial, patients with oligometastatic CRPC with three or fewer bone metastases on whole-body MRI with diffusion-weighted MRI (WB-DWI) will be randomized in a 1:1 ratio to receive radiotherapy for active metastases plus radium-223 or radiotherapy for active metastases alone. The prior use of androgen receptor axis-targeted therapy and prostate-specific antigen doubling time will be used as allocation factors. The primary endpoint will be radiological progression-free survival against progression of bone metastases on WB-DWI. DISCUSSION: 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.

Indexed as

Awards and PrizesProstatic Neoplasms, Castration-ResistantDiffusion Magnetic Resonance ImagingHumansMaleNeoplasm MicrometastasisRadiumRadiumRadium-223Castration-resistantNeoplasm metastasisProstatic NeoplasmsRadiotherapyRadium-223Randomized controlled trial

Identifiers

PMID36879257
PMCPMC9987040
OpenAlexW4323314690

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.