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Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer

NCT07717099 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-21

No results posted yet for this study

Summary

GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise from concurrently targeting androgen receptor signaling pathways and bone metastases.

Conditions

  • Metastatic Hormone-Sensitive Prostate Cance

Interventions

DRUG

Ra223

Six intravenous administrations of Radium-223 chloride, in a dose of 55 kBq/kg body weight standard dose with a treatment interval between administrations of 4 weeks. Treatment with Ra223 could be prematurely discontinued in case of progression, unacceptable toxicity, withdrawal or death.

DRUG

Darolutamide Oral Tablet

Darolutamide at 600 mg twice daily. Darolutamide administration will continue until progression, unacceptable toxicity, withdrawal or death, whichever comes first.

OTHER

Androgen Deprivation Therapy (ADT)

Standard of care ADT (surgical or drug). Administration will continue until progression, unacceptable toxicity, withdrawal or death, whichever comes first.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • MFAR

    collaborator OTHER

  • Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD

    lead OTHER

Principal Investigators

  • David Lorente, M.D., Ph.D. · Instituto Valenciano de Oncología

  • Guillermo de Velasco, M.D., Ph.D. · Hospital Universitario 12 de Octubre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07717099 on ClinicalTrials.gov