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*

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* - Rhenium combined with Docetaxel in prostate cancer metastatic to bone

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39120

Enrollment

Registered

2011-08-19

Start date

2012-08-31

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Randomisation between: - Docetaxel 75 mg/m2 3-weekly for a maximum of 10 cycles and - 3 cycles Docetaxel 75 mg/m2, followed by a gift Rhenium-188 HEDP, followed by 3 cycles Docetaxel 75 mg/m2, foll

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Prostate carcinoma;- Bone metastases;- Hormone therapy resistent

Exclusion criteria

Exclusion criteria: - Previous exposure to Rhenium or Docetaxel;- Bone marrow insufficiency

Design outcomes

Primary

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

Secondary

Measure	Time frame
- To compare PSA response rates - To compare overall survival - To determine the effects of these two treatment regimens on pain response, in patients with pain and quality of life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)