Phase 1
Completed N=32
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT00328614 ↗Enrolled (actual)
32
Serious AEs
40.0%
Results posted
Nov 2013
Primary outcomePrimary: Maximum Tolerated Dose of Samarium-153 — 2.0 mCi/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Samarium-153 |
2.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00328614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.