A randomised phase II study of repeated Rhenium-188 HEDP combined with Docetaxel versus Docetaxel alone in castration resistant prostate cancer (CRPC) metastatic to bone*

Phase 2

Completed

• Conditions: Prostate cancer; 10038597

• Registration Number: NL-OMON39120
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

- Prostate carcinoma;- Bone metastases;- Hormone therapy resistent

Exclusion Criteria

- Previous exposure to Rhenium or Docetaxel;- Bone marrow insufficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare time to progression (clinical i.e. change of treatment required, or<br /><br>Biochemical i.e. PSA) in men with progressive CRPC involving bone between<br /><br>standard care of 3-weekly Taxotere 75mg/m2 (to maximum 10 cycles) VERSUS<br /><br>3-weekly Taxotere 75mg/m2 + 2 infusions of Rhenium-188 HEDP </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare PSA response rates<br /><br>- To compare overall survival<br /><br>- To determine the effects of these two treatment regimens on pain response, in<br /><br>patients with pain and quality of life.</p><br>