153Sm-EDTMP versus docetaxel for multiple painful osseous metastases in prostate cancer

153Sm-EDTMP versus docetaxel for multiple painful osseous metastases in prostate cancer - 153Sm-EDTMP vs docetaxel

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30762

Enrollment

Registered

2006-12-21

Start date

2007-03-14

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

prostate cancer prostate carcinoma

Interventions

group 1: docetaxel 75mg/m2 every 3 weeks group 2: 150 MBq 153Sm-EDTMP once

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. more than one painful osseous metastasis from prostate cancer that can not be treated by external beam radiotherapy 2. bone metastases with uptake at pre-treatment bone scintigraphy 3. serum testosterone at castrate levels 4. WHO performance status 0-2 5. Adequate bone marrow function (ANC> 1.5 109/l, Thr > 100 109/l) 6. creatinine clearance > 60 ml/min 7. Adequate hepatic function (bilirubin

Exclusion criteria

Exclusion criteria: 1. signs of myelumcompression due to spinal or epidural metastases. 2. earlier docetaxel chemotherapy for prostate cancer 3. earlier radionuclide treatment for prostate cancer 4. inability to sign informed consent or record VAS pain diary

Design outcomes

Primary

Measure	Time frame
Pain relief / analgetics use at 6weeks	—

Secondary

Measure	Time frame
Number of patients that receive crossover treatment Pain relief after crossover Evaluation of toxicity related withdrawals	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)