Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival ā¦ (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 range18 Years
SexMALE
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Inclusion criteria
ā. Patient is able and willing to provide informed consent.
ā. Metastatic castration-sensitive prostate cancer (mCSPC) at screening with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
ā. Men ā„ 18 years.
ā. ECOG performance status of 0, 1 or 2 at screening.
ā. Metastatic to bone with ā„ 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.
ā. 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.
ā. On bone health agents with at least one dose of BHA prior to first dose of blinded IP.
ā. Adequate bone marrow and organ function as defined by:
Exclusion criteria
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.
ā. Pathological finding consistent with small cell carcinoma of the prostate.
ā. Prior treatment for mCSPC \[excluding ADT ā¤120 days and first-generation ARI (bicalutamide, nilutamide or flutamide) for ā¤120 days when initiating ADT\], 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 ā„ 1 year prior to randomization)
ā. Treatment for mCSPC with ADT starting \>120 days prior to randomization.
ā. Treatment for mCSPC with first generation ARI (bicalutamide, nilutamide or flutamide) starting \>120 days prior to randomization.
ā. Prior hemi-body or whole-body external radiotherapy.
ā. 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).
ā. Prior treatment with:
ā. Current involvement in any drug or device trial involving investigational agent or medical device within the last 28 days prior to randomization.