A randomised study to compare combination therapy of Rhenium with Docetaxel versus Docetaxel alone in patients with prostate cancer no longer sensitive to hormonal treatment and bone metastases

• Conditions: Men with castration resistant prostate cancer (CRPC) metastatic to bone; MedDRA version: 16.1Level: LLTClassification code 10036921Term: Prostate carcinomaSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10005993Term: Bone metastasesSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018044-18-NL
• Lead Sponsor: Meander MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-31
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Prostate carcinoma
- Bone metastases
- Hormone therapy resistent
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

- Previous exposure to Rhenium or Docetaxel
- Bone marrow insufficiency

Study & Design

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