Conditions: Metastatic Cancer Prostate Cancer
Keywords: stage IV prostate cancer recurrent prostate cancer bone metastases
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca) chloride aqueous solution, may help predict progressive disease in patients with prostate cancer and bone metastasis.

PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution works in diagnosing patients with prostate cancer and bone metastasis.

Detailed description:
OBJECTIVES:

Primary

* To measure the pharmacokinetics of a single oral dose of calcium-41 (41Ca) chloride aqueous solution (\^41Ca) over 18 months in patients with hormone-refractory prostate cancer and bone metastasis.
* To correlate the \^41Ca-tracer kinetics with time to disease progression, skeletal-related events, and death.

Secondary

* To correlate modulations in baseline urinary \^41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and PSA.
* To combine bone turnover assessments with \^41Ca and collagen/bone cell biomarkers with clinical imaging techniques, especially isotope bone scans, to provide improved stratification of disease stage.

OUTLINE: Patients receive oral calcium-41 (41Ca) chloride aqueous solution (\^41Ca) on day 1. Some patients also receive oral calcium-46 (46Ca) chloride aqueous solution (\^46Ca).

Urine and blood specimens are collected periodically for 18 months. Blood samples are assayed for bone collagen residues, bone alkaline phosphatase, and PSA. Urine specimens are assessed for \^41Ca/Ca. Isotope bone scintigraphy is use to measure radioactivity.

After completion of study treatment, patients are followed up periodically for 3 years.

Arms:
arm 1: None

Interventions: intervention 1: 41 Ca
Intervention descriptions: intervention 1: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.

Protocol document: