A study, in patients with prostate cancer that has spread to the bones, investigating the efficacy of radium-223 dichloride given as a 50kBq/kg dose every four weeks or a 80kBq/kg dose every four weeks in radium-223 dichloride naive patients for six doses or as a 50kBq/kg every four weeks to patients who have already been treated with a course of six doses of radium-223 dichloride

Phase 1

• Conditions: Castration resistant prostate cancer with bone metastasis; MedDRA version: 16.1Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003118-42-FI
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-24
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 360

Inclusion Criteria

- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Castration-resistant disease defined as:
-- Serum testosterone level: = 50 ng/dL (1.7 nmol/L)
-- Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
-- Serum PSA (Prostate specific sntigen) progression defined as 2 subsequent increases in PSA over a
previous reference value (a minimum of 2 ng/mL [µg/L])
OR
-- Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone.
- Two or more skeletal metastases (= 2 hot spots) on bone scintigraphy within 8 weeks of randomization
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

- History of visceral metastasis, or visceral metastases
- Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
- Central nervous system (CNS) metastases
- Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to
randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the
treatment period or follow-up
- Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone)
- Prior treatment with radium-223 dichloride
- Prior systemic radiotherapy and hemibody external radiotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified