Clinical trial · Interventional
Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
NCT00328614CI-TRIAL-00089775completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Device | — | UNRESOLVED |
| Samarium-153 | Drug | — | UNRESOLVED |
| Total Androgen Suppression (TAS) with Bicalutamide | Drug | — | UNRESOLVED |
| Total androgen suppression (TAS) with Goserelin Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Samarium-153 (0.25 mCi/kg)
- description
- Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
- interventionNames
- Drug: Samarium-153
- Drug: Total Androgen Suppression (TAS) with Bicalutamide
- Drug: Total androgen suppression (TAS) with Goserelin Acetate
- Device: Radiation Therapy
- type
- EXPERIMENTAL
- label
- Samarium-153 (0.5 mCi/kg)
- description
- Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
- interventionNames
- Drug: Samarium-153
- Drug: Total Androgen Suppression (TAS) with Bicalutamide
- Drug: Total androgen suppression (TAS) with Goserelin Acetate
- Device: Radiation Therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.