A Phase I Trial of Samarium-153-Lexidronam Complex for Treatment of Clinically Nonmetastatic High-Risk Prostate Cancer: First Report of a Completed Study

Journal Article · Tue Mar 01 00:00:00 EST 2011 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2009.11.011· OSTI ID:21491606

Trabulsi, Edouard ^[1]; Intenzo, Charles ^[2]; Lavarino, Jorosali ^[3]; Yihuan, Xu; Chervoneva, Inna ^[4]

---

1. Department of Urology, Thomas Jefferson University, Jefferson Medical College, Philadelphia, PA (United States)
2. Department of Radiology, Thomas Jefferson University, Jefferson Medical College, Philadelphia, PA (United States)
3. Department Radiation Oncology, University of California Davis School of Medicine, Sacramento, CA (United States)
4. Department of Pharmacology, Thomas Jefferson University, Jefferson Medical College, Philadelphia, PA (United States)

Purpose: We completed a Phase I trial to determine the maximum tolerated dose of samarium-153 EDTMP ({sup 153}Sm) 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 {sup 153}Sm-EDTMP (.25-2.0 mCi/kg) as primary or postoperative therapy. After 1 month of HT, we administered {sup 153}Sm-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 {sup 153}Sm-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; 2.0mCi/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 {sup 153}Sm -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.

• OSTI ID: 21491606
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Vol. 79, Issue 3; Other Information: DOI: 10.1016/j.ijrobp.2009.11.011; PII: S0360-3016(09)03523-8; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CLINICAL TRIALS
HORMONES
NEOPLASMS
PROSTATE
RADIATION DOSES
RADIOTHERAPY
SAMARIUM 153
TOXICITY
BETA DECAY RADIOISOTOPES
BETA-MINUS DECAY RADIOISOTOPES
BODY
DAYS LIVING RADIOISOTOPES
DISEASES
DOSES
EVEN-ODD NUCLEI
GLANDS
INTERMEDIATE MASS NUCLEI
ISOTOPES
MALE GENITALS
MEDICINE
NUCLEAR MEDICINE
NUCLEI
ORGANS
RADIOISOTOPES
RADIOLOGY
RARE EARTH NUCLEI
SAMARIUM ISOTOPES
TESTING
THERAPY