Trial Condition(s):

Hormone Refractory Prostate Cancer, Bone Metastases

BAY88-8223, does response study in HRPC patients

Bayer Identifier:

15305

ClinicalTrials.gov Identifier:

NCT00667199

EudraCT Number:

2004-000299-15

Study Completed

Trial Purpose

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 no longer respond to hormonal treatment.

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nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required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

Trial Summary

Enrollment Goal
100
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design