Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Radium Ra 223 dichloride

Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.

Enzalutamide administered as a single agent for 6 28-day cycles.

Radium Ra 223 Dichloride, 55 kilobecquerel (kBq)/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.

Radium Ra 223 Dichloride

Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles.

Enzalutamide

Study of Radium Ra 223 dichloride with enzalutamide compared to enzalutamide alone in men with metastatic castration refractory prostate cancer

Radium Ra 223 With Enzalutamide Compared to Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer

A Phase 2 Randomized Study Comparing Radium Ra 223 Dichloride Plus Enzalutamide With Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer

Patients had serum N-telopeptide labs drawn prior to the start of treatment and at the End of Treatment visit or at disease progression, whichever occurred first. The mean and standard deviation of the differences were calculated on a log 2 scale. Fold changes (post/pre) and 95% confidence intervals are reported.

Adverse Events were assessed from start of Radium Ra 223 Dichloride or Enzalutamide treatment (whichever was started first) through 30 days after the last dose of either drug or until start of a new anti-cancer therapy, whichever came first. Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4.0. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. Reported below are the number of patients who experienced any grade 3-5 non-hematological AE. A full listing of AEs affecting 5% or more participants are listed in the Adverse Events module of the Results section.

Prostate Specific Antigen (PSA) Progression Free Survival (PFS) is the time during with participants did not experience PSA progression. This is measured from the start of study therapy to the time of PSA progression. PSA progression is defined as a rise in PSA of at least 25% and at least 2 ng/ml from baseline or nadir. Kaplan-Meier methods were used.

Radiographic Progression Free Survival (PFS) is the time during with participants did not experience disease progression based on study imaging. This is measured from the start of study therapy to the time of radiographic progression. Radiographic progression was defined by the Prostate Cancer Working Group 2 (PCWG2) criteria, in which soft tissue disease is evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and bone lesions are evaluated separately under PCWG2 criteria. PCWG2 and RECIST 1.1 are established radiographic assessment protocols. Kaplan-Meier methods were used.

Bone Alkaline Phosphatase (ALP) Progression Free Survival (PFS) is the time during with participants did not experience Bone ALP progression. This is measured from the start of study therapy to the time of Bone ALP progression. Bone ALP progression defined as a rise in Bone ALP of at least 25% and at least 2 micrograms (mcg)/L from baseline or nadir. Kaplan-Meier methods were used.

Prostate Specific Antigen (PSA) Responses in participants were categorized based on decrease from baseline: less than 30% (\<30%) decrease (including increases from baseline), greater than or equal to 30% (\>=30%) decrease, greater than or equal to 50% (\>=50%) decrease, and greater than or equal to 90% (\>=90%) decrease. Count of participants in each category are provided

Radiographic Responses in participants were assessed using the Prostate Cancer Working Group 2 (PCWG2) criteria. Possible responses include Complete Response (CR) (complete disappearance of all metastatic disease on imaging), Partial Response (PR) (improvement in metastatic disease on imaging), Stable Disease (SD) (neither worsening nor improvement of metastatic disease on imaging), and Progressive Disease (PD) (worsening of metastatic disease on imaging). A count of participants in each category is provided here.

Overall Survival (OS) is the time during which participants did not pass away. This is measured from the start of study therapy to the time of death from any cause. Kaplan-Meier methods were used.

University of Utah

The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events also may have been detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.

Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.

Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kBq/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.

Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles.

Radium Ra 223 Dichloride and Enzalutamide

Enzalutamide administered as a single agent for 6 28-day cycles.

Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles.

Enzalutamide Alone

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Two patients on the Enzalutamide only arm did not have subsequent N-Telopeptide labs drawn and were excluded from the N-Telopeptide analysis, so are excluded here as well.

Serum N-Telopeptide Levels (Log2 scale)

Data Manager

Per study protocol, only randomized patients with bone marker level measurements at baseline and Cycle 3 Day 1 will be evaluable for the primary efficacy outcome. 8 patients were assigned to Radium + Enzalutamide without randomization and were excluded from analysis. 2 patients on Enzalutamide alone did not reach Cycle 3 Day 1 and were excluded.

Fold Change in Serum N-telopeptides From Baseline

Number of Participants With Adverse Events

Radium Ra 223 Dichloride and Enzalutamide administered concurrently for 6 28-day cycles.

Radium Ra 223 Dichloride: Radium Ra 223 Dichloride, 55 kilobecquerel (kBq)/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.

Enzalutamide: Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles.

Spots Global Cancer Trial Database for Radium Ra 223 With Enzalutamide Compared to Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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