At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed prostate carcinoma
- ✓Osteoblastic metastases on bone scan or CT scan
- ✓Initiation of hormonal ablative therapy within 3 months of registration
- ✓Prior hormonal therapy allowed if <3 years duration and completed ≥3 years before entry
- ✕More than one prior chemotherapy regimen; cumulative doxorubicin >250 mg/m2
- ✕Prior radioisotope treatment (strontium-89 or samarium-153)
- ✕Zoledronic acid for >3 months prior to registration
- ✕Brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Study Of Bone-Targeted Therapy In Advanced Androgen-Dependent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Doxorubicin hydrochloride, Goserelin acetate, and 4 other interventions for Metastatic Cancer and Prostate Cancer. Completed, enrolled 80 participants across 4 sites.
Detailed Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin and leuprolide may fight prostate cancer by stopping the adrenal glands from producing androgens. Drugs used in chemotherapy such as doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether hormone (androgen) ablation therapy and chemotherapy combined with zoledronate is more effective with or without strontium-89 in treating prostate cancer and bone metastases. PURPOSE: This randomized phase II trial is studying giving hormone ablation therapy, doxorubicin, and zoledronate together with strontium-89 to see how well it works compared to hormone ablation therapy, doxorubicin, and zoledronate alone in treating patients with androgen-dependent prostate cancer and bone metastases.
Study Details
Timeline
Interventions
Doxorubicin 20 mg/m\^2 is administered intravenously either over 15 to 30 minutes via a peripheral line or over 24 hours via a central line on days 1, 8, and 15 every 28 days for 2 cycles.
4 mg given intravenously over 15 minutes every 28 days for a total of 6 doses.
1 dose of strontium-89 (4 millicurie (mCi) total dose) administered intravenously on the first day of treatment