Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborator: Cytogen Corporation
• Treatments: Androgens; Ascorbic Acid; Bicalutamide; Estrogens, Conjugated (USP); Ethylene; Goserelin; Methyltestosterone; Samarium ethylenediaminetetramethylenephosphonate; Samarium Sm-153 lexidronam

Criteria

Inclusion Criteria:

• PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150

• Pathologically positive lymph nodes

• Pretreatment must be prior to study entry and prior to any hormonal therapy

• Zubrod 0-1

• Adequate hematologic function

Exclusion Criteria:

• Patients with PSA equal to or greater than 150

• Neuroendocrine features on histologic examination

• Radiologic evidence of metastatic disease

• Previous malignancy within last 5 years

• Prior pelvic radiation therapy or orchiectomy