Prostate cancer that has spread to the bone
Conditions
Interventions
Re-188-HEDP will be administered in a split dose of 18.5 MBq/kg with 2 weeks
interval through an established intravenous (IV) line over a period of 1
minute.15 successive patients will be treated. I
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically documented prostate carcinoma; presence of osteoblastic bone metastases; hormone refractory disease; bone pain; life expectancy of at least 3 months; informed consent.
Exclusion criteria
Exclusion criteria: Previous chemotherapy within 6 weeks prior to screening; prior treatment with systemic radiotherapeutic bone agent within a specified period; previous external beam radiotherapy within a specified period; active CNS or epidural metastases. ANC 5 microgram/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and toxicity profile of a split dose regimen will be determined. Efficacy will be determined from PSA scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biodistribution will be compared to historical data of single Re-188-HEDP therapy. Efficacy will be determine from pain scores, analgesic consumption, symptom evaluation and HRQOL scores and bone metabolism (bone marker analysis). | — |
Countries
Netherlands
Outcome results
None listed