MedTrace Logo

Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

NCT05771896 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-14

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)

The main questions it aims to answer are:

* Radiological progression-free survival (rPFS) in mCSPC
* Overall Survival (OS)
* Symptomatic skeletal event-free survival (SSE-FS)
* Initiation of subsequent antineoplastic therapy
* Safety

Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.

Conditions

Interventions

DRUG

Darolutamide

Participants will continue treatment with darolutamide until radiological progression, withdrawal, death, termination, or study completion. The maximum time for darolutamide dose interruption period is 28 consecutive days beyond scheduled dose (\>56 days between cycles). Any participant requiring dose interruption \>28 consecutive days beyond the scheduled dose may restart treatment with darolutamide if clinical benefit is anticipated and after discussion with and approval from the study Medical Monitor. Until primary endpoint is reached, participants are not allowed to switch ARPI (Abiraterone, Apalutamide or Enzalutamide) during the study. Switching to other ARPI following radiographic progression should be considered a subsequent life prolonging therapy and documented accordingly.

DRUG

Radium-223

Radium-223 should be given for 6 cycles, administered IV on Day 1 of each cycle or until radiological progression, withdrawal, death, termination, or study completion. The placebo will be administered in precisely the same fashion as the active drug. Subsequent cycles 2-6 should be scheduled to occur every 28 ± 7 days following the previous cycle, but dosing may be delayed up to 28 days per cycle (maximum 56 days between cycles). Any participant requiring dose interruption \>28 consecutive days (\>56 days between cycles) may restart treatment with radium-223/placebo if clinical benefit is anticipated and after discussion with the Medical Monitor. Participants will continue with darolutamide irrespective of Radium-223 administration. Upon radiological progression, further treatments are decided by the site investigator according to standard local practice.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • GenesisCare USA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2028-12-31
Completion
2029-04-30
FDA Drug
Yes

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 NCT05771896 on ClinicalTrials.gov