Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival … (NCT05771896) | Clinical Trial Compass
WithdrawnPhase 3
Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC
Stopped: Bayer withdrew their support.
0Started 2023-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is able and willing to provide informed consent.
. Metastatic castration-sensitive prostate cancer (mCSPC) at screening with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
. Men ≥ 18 years.
. ECOG performance status of 0, 1 or 2 at screening.
. Metastatic to bone with ≥ 2 bone metastases (area of increased uptake on 99mTc methylene diphosphonate bone scan); equivocal lesions on the bone scan must be confirmed by standard X-ray, CT, or MRI.
. Ongoing ADT by Investigator's choice with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or bilateral orchiectomy for less than 120 days prior to randomization. ADT treatment should be on a stable dose without interruptions of at least 4 weeks prior to first dose of blinded IP.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiological progression-free survival (rPFS) in mCSPC patients
Timeframe: First occurrence bone scan progression and/or soft tissue progression per #RECIST 1.1 criteria, participant dies, withdraws consent and/or study is terminated, whichever comes first.
. On bone health agents with at least one dose of BHA prior to first dose of blinded IP.
. Adequate bone marrow and organ function as defined by:
Exclusion criteria
. Pathological finding consistent with small cell carcinoma of the prostate.
. Prior treatment for mCSPC \[excluding ADT ≤120 days and first-generation ARI (bicalutamide, nilutamide or flutamide) for ≤120 days when initiating ADT\], with the exception of Metastases Directed Therapy (MDT) with EBRT/SBRT (at least 2 bone metastases must be untreated). Prior treatment for localized prostate cancer is allowed (all treatments must have been completed ≥ 1 year prior to randomization)
. Treatment for mCSPC with ADT starting \>120 days prior to randomization.
. Treatment for mCSPC with first generation ARI (bicalutamide, nilutamide or flutamide) starting \>120 days prior to randomization.
. Prior hemi-body or whole-body external radiotherapy.
. Prior therapy with radionuclides (e.g., including but not limited to radium-223, strontium-89, samarium-153), including prior therapy with investigational radionuclides (e.g., including but not limited to iodine-131, rhenium-186, rhenium- 188, thorium- 277, actinium-225 and lutetium-177).
. Prior treatment with:
. Current involvement in any drug or device trial involving investigational agent or medical device within the last 28 days prior to randomization.