Prostate Cancer Clinical Trial

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

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.

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Full 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 hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.

The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT00328614

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT00328614

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Cancer Center at Thomas Jefferson University

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