Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the prostate
Hormone refractory with evidence of rising prostate-specific antigen (PSA): Subject must be maintained on androgen ablation therapy with luteinizing hormone-releasing hormone agonist or have undergone bilateral orchiectomy
Serum testosterone level required to be ≤50 ng/dL
Subjects who have received prior antiandrogen drug therapy: Flutamide, nilutamide, or cyproterone acetate must have stopped at least 4 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation; bicalutamide must have stopped at least 6 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation
PSA progression: Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur at a minimum of 1 week from the reference value (measure 1). This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the subject will still be eligible provided the next PSA measure (measure 4) is found to be greater than the second PSA value (measure 2)
Skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
Life expectancy: ≥6 months
Laboratory requirements: Neutrophil count ≥1.5 x 109/L, platelet count ≥100 x109/L, haemoglobin ≥95 g/L, total bilirubin level within normal institutional limits, aspartate aminotransferase and alanine aminotransferase ≤2.5 times upper institutional limit of the normal range, S Creatinine ≤1.5 times upper institutional limit of the normal range
You may not be if
Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
More than one regimen of previous cytotoxic chemotherapy
Has received prior hemibody external radiotherapy
Has a need for immediate external radiotherapy
Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for \>/= 12 weeks before administration of study drug
Patients who are \</= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
Patients who have started or stopped systemic steroids, within a week prior to study drug administration, or are expected to be subject to changes in the systemic steroid medication
Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
Visceral (e.g. liver, lung) metastases from prostate cancer as assessed by abdominal/ pelvic CT or chest radiograph within six weeks before administration of study drug
Lymph node metastases with short-axis diameter greater than 2 cm
Bulky loco-regional disease
Any other serious illness or medical condition, for example: any uncontrolled infection, any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV), Crohns disease or ulcerative colitis
Clareo Health | PK in Pts With HRPC & Skeletal Metastes
