A randomised phase III trial of docetaxel plus prednisolone vs docetaxel with prednisolone plus either zoledronic acid, strontium-89 or both agents combined

Phase 3

Completed

• Conditions: Prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN12808747
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26794729 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27434595 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27256016 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-08
• Study Completion: 2016-03-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 618

Inclusion Criteria

1. Age >18 years
2. Histologically/cytologically proven prostate cancer or multiple sclerotic bone metastases with prostate specific antigen (PSA) >100 ng/ml without histological confirmation
3. Radiological evidence of bone metastatsis
4. Prior hormonal therapy for prostate cancer, resulting in serum testosterone <50 ng/dl: bilateral orchidectomy, and/or medical castration by LHRH agonist therapy
5. Documented disease progression, defined by one of the following: elevated PSA (progressive rise) and/or progression of any unidemensionally or bidimensionally measurable malignant lesion at least one new lesion identified on bone scan
7. Life expectancy >3 months
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. Adequate haematological function
10. Adequate renal and hepatic function
11. Written Informed Consent

Exclusion Criteria

1. Prior cytotoxic chemotherapy for HRPC, other than estramustine monotherapy
2. Prior radiotherapy to more than 25% of the bone marrow or whole pelvic irradiation
3. Prior radionuclide therapy for HRPC
4. Prior tretament with a bisphosphonate for any reason within previous 2 months
5. Malignant disease within the previous 5 years, other than adequatly treated basal cell carcinoma
6. Known brain or leptomeningeal metastases
7. Symptomatic peripheral neuropathy >grade 2 (NCI CTC)
8. Known hypersensitivity to bisphosphonates
9. Concurrent enrolment in any other investigational clinical trial
10. Treatment with any other investigational compound within previous 30 days
11. Any condition, which, in the opion of the investigator, might interfere with the safety or evaluation of the study objectives

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 15/01/2009:<br> The following will be assessed every month for the first three months and then every three months until death:<br> 1. Toxicity and tolerability of docetaxel + synchronous zoledronic acid (Zometa®)<br> 2. Toxicity and tolerability of docetaxel + sr-89<br> 3. Toxicity and tolerability of docetaxel + synchronous zoledronic acid (Zometa®) + Sr-89<br><br> Previous primary outcome measures:<br> 1. Toxicity and Tolerablity of Docetaxel + Synchronous Zoledronic acid (Zometa)<br> 2. Toxicity and tolerablity of Docetaxel + Sr-89<br> 3. Toxicity and tolerablity of Docetaxel + synchronous Zoledronic acid (Zometa) + Sr-89<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Health care economic analysis<br> 2. Changes in bone mineral density<br> 3. Biological profiling for prognostic and predictive indicators<br>