A Phase I trial of samarium-153-lexidronam complex for treatment of clinically nonmetastatic high-risk prostate cancer: first report of a completed study.
Publication/Presentation Date
3-1-2011
Abstract
PURPOSE: We completed a Phase I trial to determine the maximum tolerated dose of samarium-153 EDTMP (153Sm) with hormonal therapy (HT) and radiation therapy (RT) in high-risk clinically nonmetastatic prostate cancer.
METHODS AND MATERIALS: High-risk M0 prostate cancer patients (prostate-specific antigen>20 ng/mL, Gleason score>7, or>T3) were eligible for this prospective trial of dose-escalated radioactive 153Sm-EDTMP (.25-2.0 mCi/kg) as primary or postoperative therapy. After 1 month of HT, we administered 153Sm-EDTMP followed by 4 more months of HT, 46.8 Gy to the pelvic region and 23.4 Gy to the prostate target (TD=70.2 Gy). The primary endpoint was Grade III toxicity or higher by the National Cancer Institute Common Toxicity Criteria.
RESULTS: Twenty-nine patients enrolled (median prostate-specific antigen=8.2 ng/mL, 27/29 (93%) T stage≥T2b, 24/29 (83%) had Gleason>7) and received 153Sm-EDTMP (.25 mCi/kg, 4 patients; 0.5 mCi/kg, 4 patients; 0.75 mCi/kg, 6 patients; 1.0 mCi/kg, 6 patients; 1.5 mCi/kg, 5 patients; 2.0 mCi/kg, 4 patients). Twenty-eight patients underwent all planned therapy without delays (1 patient required surgery before the start of RT). With a median follow-up time of 23 months, there were 2 patients (7%) experiencing Grade III hematologic toxicity. There were no other Grade III or IV side effects.
CONCLUSIONS: Our trial demonstrates that 2 mCi/kg 153Sm -EDTMP with HT and RT was safe and feasible in men with high-risk M0 prostate cancer. A Phase II study to test this treatment is currently underway by the Radiation Therapy Oncology Group.
Volume
79
Issue
3
First Page
732
Last Page
737
ISSN
1879-355X
Published In/Presented At
Valicenti, R. K., Trabulsi, E., Intenzo, C., Lavarino, J., Xu, Y., & Chervoneva, I. (2011). A Phase I trial of samarium-153-lexidronam complex for treatment of clinically nonmetastatic high-risk prostate cancer: first report of a completed study. International journal of radiation oncology, biology, physics, 79(3), 732–737. https://doi.org/10.1016/j.ijrobp.2009.11.011
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
20399029
Department(s)
Administration and Leadership
Document Type
Article