My Clinical Trial
The CenterWatch Information That Got Me Started
This is what I found at CenterWatch that got me started.
Summary: Advanced prostate cancer treated with hormones, where the treatment is no longer effective and the cancer has spread to the bones, but is not causing pain.
This study is randomized (i.e., similar to a coin toss), placebo-controlled and double-blind (i.e., patient and assessing physician does not know treatment during the study). There is a 2:1 ratio between patients who will receive active drug and those who will receive placebo. The study is designed to assess the effect and safety of two dose levels of Quadramet administered intravenously every 16 weeks in delaying the development of pain associated with cancer spread to bones in patients with prostate cancer that is no longer responding to hormones.
Men at least 18 years of age with bone scan positive metastases (that are not yet causing pain) secondary to hormone-refractory prostate carcinoma will be recruited for this study.
Summary of key inclusion criteria:
Summary of key exclusion criteria:
- Prostate cancer, documented by microscopic examination of tissue, which has progressed after initial hormonal therapy (as evidenced by at least two successive increases in PSA totaling at least 3 ng/mL above the lowest level).
- Cancer spread to bones confirmed by a positive bone scan.
- Must consent to catheterization of the bladder for up to 6 hours after study agent administration, if patient has urinary tract obstruction or incontinence.
- Painful cancer spread to bones, or prior radiotherapy or chemotherapy directed at treatment of pain due to cancer spread to bone.
- Taking opioid pain medications or any pain medicine that is greater than 15 oral morphine equivalents per day.
- Pain greater than 4 on a 10-point scale.
- Arm/leg fractures, cancer in arms/legs likely to result in a fracture, or spinal column fracture/collapse.
- Known allergies to phosphonate compounds.
- Active angina or known heart disease that restricts or limits daily activity.
- Medical history of bleeding disorders.
234 Goodman St.
Cincinnati, OH 45267-0577
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