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Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

NCT04319783 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-21

No results posted yet for this study

Summary

Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that \>90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.

Conditions

  • Advanced Prostate Carcinoma
  • Cancer of Prostate
  • PSA
  • Castrate Resistant Prostate Cancer

Interventions

DRUG

Darolutamide

Darolutamide alone

RADIATION

Radiotherapy

Darolutamide + Consolidation Radiotherapy

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Shankar Siva · Peter MacCallum Cancer Centre, Australia

  • Arun Azad · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Australia
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04319783 on ClinicalTrials.gov