Who is sponsoring NCT03458559?

NCT03458559 is sponsored by Amsterdam UMC, location VUmc.

What drugs are being tested in NCT03458559?

Interventions in NCT03458559: Radium-223 chloride, Rhenium-188-HEDP.

What condition does NCT03458559 study?

NCT03458559 studies Prostate Cancer Metastatic to Bone.

Is NCT03458559 still recruiting?

NCT03458559 is currently status unknown. Last updated 17 November 2020.

Last reviewed 2020-11-17 · How we verify

NCT03458559: RaRe

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy

Status unknown Phase 3 Last updated 17 November 2020

What this trial tests

Phase 3 trial testing Radium-223 chloride in Prostate Cancer Metastatic to Bone in 402 participants. Status unknown.

Timeline

16 May 2018

Primary endpoint
16 May 2022

16 May 2024

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	402
Start date	16 May 2018
Primary completion	16 May 2022
Estimated completion	16 May 2024
Sites	1 location across Netherlands

Drugs / interventions tested

Radium-223 chloride — full drug profile →
Rhenium-188-HEDP — full drug profile →

Conditions studied

Prostate Cancer Metastatic to Bone — all drugs for Prostate Cancer Metastatic to Bone →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

18 and older, male only, with Prostate Cancer Metastatic to Bone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Radium-223 chloride is an alpha-emitting radiopharmaceutical with proven survival benefit in patients with castration-resistant prostate cancer metastatic to bone. Beta-emitting radiopharmaceuticals have proven efficacy for palliating malignant bone pain. Nowadays, rhenium-188-HEDP is used in clinical practice for pain relief and palliative care. Several studies suggest that also rhenium-188-HEDP has the potential to improve overall survival. The purpose of this study is to investigate if treatment with rhenium-188-HEDP results in improvement of overall survival compared to treatment with radium-223-chloride.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment of Advanced Prostate Cancer.
Teo MY, Rathkopf DE, Kantoff P. · · 2019 · cited 516× · PMID 30691365 · DOI 10.1146/annurev-med-051517-011947
The treatment landscape of metastatic prostate cancer.
Yamada Y, Beltran H. · · 2021 · cited 98× · PMID 34153403 · DOI 10.1016/j.canlet.2021.06.010
Rhenium-188 Labeled Radiopharmaceuticals: Current Clinical Applications in Oncology and Promising Perspectives.
Lepareur N, Lacœuille F, Bouvry C, Hindré F, et al · · 2019 · cited 69× · PMID 31259173 · DOI 10.3389/fmed.2019.00132
Clinical Advances and Perspectives in Targeted Radionuclide Therapy.
Lepareur N, Ramée B, Mougin-Degraef M, Bourgeois M. · · 2023 · cited 44× · PMID 37376181 · DOI 10.3390/pharmaceutics15061733
Rhenium Radioisotopes for Medicine, a Focus on Production and Applications.
Uccelli L, Martini P, Urso L, Ghirardi T, et al · · 2022 · cited 16× · PMID 36014521 · DOI 10.3390/molecules27165283
Radiometals in Imaging and Therapy: Highlighting Two Decades of Research.
Sharma S, Pandey MK. · · 2023 · cited 13× · PMID 37895931 · DOI 10.3390/ph16101460
An overview of current phase 3 radiopharmaceutical therapy clinical trials.
Lepareur N. · · 2025 · cited 1× · PMID 40041466 · DOI 10.3389/fmed.2025.1549676

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03458559 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amsterdam UMC, location VUmc
Last refreshed: 17 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03458559.

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