A double blind, randomised, dose finding, repeat dose, phase II, multicentre study of Alpharadin TM for the treatment of patients with hormone refractory prostate cancer and skeletal metastases. - N/A

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 0

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate.
2. Hormone refractory with evidence of rising PSA.
3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 12 weeks
4. Performance status: ECOG 0-2
5. Life expectancy: At least 6 months
6. Laboratory test results within required parameters.
7. The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination
8. The patient has been fully informed about the study and has signed the informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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
2. 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
3. More than one regimen of previous cytotoxic chemotherapy. Estramustine phosphate is allowed in addition to one regimen of a cytotoxic chemotherapy
4. Has received prior hemibody external radiotherapy.
5. Has a need for immediate external radiotherapy
6. 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 administration of study drug
7. 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.
8. Patients who are <= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
9. Patients who have started on systemic steroids, within a week prior to study drug administration or who have stopped steroids within a week prior to study drug administration
10. Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
11. Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within eight weeks before administration of study drug; Lung lesions from prostate cancer as assessed by Chest Xray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable.
12. Bulky loco-regional disease
13. Other serious illness or medical condition.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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