BAY88-8223, Does Response Study in HRPC Patients

• Status: Completed
• Trial end date: 2009-10-06
• Target enrollment: 0
• Participant gender: Male

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 no longer respond to hormonal treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Radium Ra 223 dichloride; Succinylcholine

Criteria

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nilutamide, megestrol acetate, polyestradiol phosphate, aminoglutethimide, and ketoconazole, has been recently withdrawn must demonstrate progression of disease and be at last 4 weeks beyond the discontinuation of such agents; for bicalutamide 6 weeks is required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