Status:
COMPLETED
BAY88-8223, Does Response Study in HRPC Patients
Lead Sponsor:
Bayer
Conditions:
Hormone Refractory Prostate Cancer
Bone Metastases
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that ...
Detailed Description
The study is designed to investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding palliation of bone ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically/cytologically confirmed adenocarcinoma of the prostate
- Patient is hormone refractory with evidence of progressive disease:
- Patient must be maintained on androgen ablation therapy with LHRH agonist or have undergone orchiectomy
- Patient's testosterone level is required to be equal to or below 50 ng/dl
- Patients in which flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required
- Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA \>/= 5 ng/ml
- A reference PSA (nadir) value must be measured at least 4 weeks after the discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after discontinuation of bicalutamide
- If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is grater than the second PSA value and \>/= 5 ng/ml
- Multifocal (\>1) skeletal metastases confirmed by bone scintigraphy within 6 weeks
- Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy
- Performance status: ECOG 0-2 or Karnofsky \>/= 60%
- Life expectancy: At least 3 months
- Age more than 40 years
- Laboratory requirements:
- Neutrophil count \>/= 1,5 x 109/L
- Platelet count \>/= 100 x109/L
- Hemoglobin \> 95 g/L
- Bilirubin within normal institutional limits
- ASAT and ALAT \<2,5 times upper limit of normal (ULN)
- The patient is willing and able to comply with the protocol (including maintenance of patient diary, completion of pain assessment forms), and agrees to return to the hospital for follow-up visits and examinations
- The patient has been fully informed about the study and has signed the informed consent form
- Exclusion criteria
- Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period
- Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Has received prior hemibody external radiotherapy
- Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium 188 for the treatment of bony metastases within the last year prior to inclusion
- Has started treatment with bisphosphonates less than 3 months prior to administration of study drug
- Patients experiencing hormone withdrawal syndrome, or are \</= 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide)
- Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223
- Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves
- Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient
- Other serious illness or medical condition:
- any uncontrolled infection
- cardiac failure Classification III or IV (New York Heart Association)
- Crohn disease or Ulcerative colitis
- known bone fracture within 8 weeks
Exclusion
Key Trial Info
Start Date :
May 30 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00667199
Start Date
May 30 2005
End Date
October 6 2009
Last Update
April 19 2023
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