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About
The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone
Enrollment
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Volunteers
Inclusion criteria
Patients with visceral metastases are not allowed. Patients with multifocal bone lesions are allowed; while patients with diffuse confluent bone lesions (superscan) are not allowed in the trial.
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to randomization. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from all blood pressure assessment timepoints must be ≤140/90 mm Hg in order for a patient to be eligible for the study.
Exclusion criteria
No known history of central nervous system metastases or leptomeningeal tumor spread.
No significant cardiovascular disease including:
patients having received docetaxel for CRPC are excluded.
No prior treatment with enzalutamide or Ra223
No prior and concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole
No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188)
No involvement in another therapeutic trial involving an experimental drug
No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization
No known hypersensitivity to compounds related to enzalutamide or Ra223
No prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer), or the patient has been free of malignancy for a period of 3 years prior to randomization date
No history of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (registration date), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arterio-venous malformation, head trauma with loss of consciousness requiring hospitalization)
No major surgery within 4 weeks prior to treatment
No intake of narcotic analgesia for bone pain
No drug or alcohol abuse
No other serious illness or medical condition, such as but not limited to:
No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation
Primary purpose
Allocation
Interventional model
Masking
446 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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