Status:
COMPLETED
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborating Sponsors:
Cytogen Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00328614
Start Date
March 1 2003
End Date
June 1 2011
Last Update
May 16 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107