Status and phase
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About
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
Full description
Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.
Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.
Enrollment
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Ages
Volunteers
Inclusion criteria
Eligible subjects will conform to all of the inclusion criteria listed below:
Subject must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Subject is willing and able to comply with the protocol, including all study visits and procedures.
Subject is a male, greater than 18 years at time of enrollment.
Life expectancy of at least 9 months.
Subject has histologically documented prostate cancer confirmed by a pathology report from a prostate biopsy or radical prostatectomy specimen.
Subject must:
• have initiated a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or
• plans to initiate a stable daily dose of Abiraterone plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
Subject must plan to receive all 6 Radium Ra 223 dichloride injections and daily oral doses of Abiraterone plus Prednisone during the trial, per protocol.
Subject has a history of bone metastasis from prostate cancer as evidenced by imaging performed within 90 days of enrollment from one of the following:
• Tc Bone Scan or
• Sodium Fluoride PET/CT Scan
*If a bone scan is used, solitary lesions which could be contributed to causes other than prostate cancer must be confirmed with a second modality (i.e.: plain films, CT Scan or MRI.
Subject has Castrate Resistant Prostate Cancer, defined as rising PSA with a testosterone level </= 50ng/dl (2.0 nM/L) while receiving androgen deprivation therapy (medical or surgical castration).
* PSA progression will be defined as at least 2 rising PSA levels taken at least 7 days apart with the 2nd PSA being 2.0 ng/dl or greater.
Subject has the presence of bone pain requiring treatment with:
• White Blood Cell (WBC) >/= 3,000/mm3
Absolute Neutrophil Count (ANC) >1500/mm3
Platelet (PLT) count >100,000/mm3
Hemoglobin (HGB) > 10.0 g/dL (100g/L; 6.2 mmol/L
Creatinine <1.5 ULN
Total bilirubin level <1.5 X ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 X ULN
albumin >25 g/L
Baseline electrolytes within normal limits ( Sodium, potassium, chloride, calcium, phosphate, magnesium, LDH, γGT, urea, total protein) 13. Normal Liver Function Tests (LFT) and normal Renal Function Tests (RFT) at screening visit. If the subject has LFT's or RFT's greater than 2.5 times the upper limit of normal (ULN), Medical Monitor review, in conjunction with the subject's PI, will be required.
Subjects receiving Anti-Resorptive medications (such as Zolendronic Acid or denosumab) must be on a stable dose for at least 90 days prior to enrollment (Cycle 1/Week 1/ Day 1). Anti-resorptive medications may be added to the subject's regimen after the End of Treatment visit has been completed. Anti-resorptive medication withdrawal will be allowed per Investigator discretion due to adverse events attributable to that medication.
Subjects of childbearing potential must agree to use adequate contraception beginning at the enrollment until at least 30 days after the last dose of the study drugs. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
Exclusion criteria
Eligible subjects must not meet any of the exclusion criteria listed below:
Primary purpose
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36 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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