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A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Samarium-153 EDTMP

Outcome Description:

To assess the safety of Samarium-153 EDTMP administered intravenously in a single dose after one month of TAS and two months prior to starting external beam radiation therapy in patients with high-risk clinically localized prostate cancer.

Outcome Time Frame:

30 days post-treatment

Safety Issue:

Yes

Principal Investigator

Edouard Trabulsi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University

Authority:

United States: Institutional Review Board

Study ID:

02C.172

NCT ID:

NCT00328614

Start Date:

March 2003

Completion Date:

June 2011

Related Keywords:

  • Prostate Cancer
  • Locally advanced prostate cancer
  • positive lymph nodes
  • Prostatic Neoplasms

Name

Location

Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541