Overview

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