Clinical trial · Interventional
Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
NCT00551525CI-TRIAL-00028767completedPhase 2Results 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)
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer. PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Samarium 153 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy + Samarium 153
- description
- Samarium 153 infusion followed by radiotherapy 12 weeks later
- interventionNames
- Radiation: Radiotherapy
- Drug: Samarium 153
Primary outcomes (1)
- measure
- Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
- timeFrame
- Twelve weeks from the date of Samarium 153 infusion.
- description
- A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically proven diagnosis of prostate cancer progressing after prior radical prostatectomy as indicated by one of the following: * Postoperative prostate-specific antigen (PSA) rising above 1.0 ng/mL * Postoperative PSA rising above 0.2 ng/mL with a surgical tumor Gleason score of 9 or 10 * Postoperative PSA rising above 0.2 ng/ml with nodal disease * Stage II-IV disease (T2 -T4, N0-N1) * No distant metastases based on the following minimum diagnostic work up: * History or physical examination within the past 8 weeks * Bone scan negative for bone metastases within the past 4 months * Abdominal imaging negative for metastases within the past 6 months Exclusion criteria: * Biopsy evidence of M1 disease * Presence of neuroendocrine features in any prostate cancer specimen PATIENT CHARACTERISTICS: Inclusion criteria: * Zubrod Performance Status 0-1 * Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³ * Platelet count ≥ 100,000 cells/mm³ * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is permitted) Exclusion criteria: * Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years * Severe, active comorbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (laboratory tests for liver function and coagulation parameters, however, are not required for entry into this protocol) * Renal failure (laboratory tests for renal function, however, are not required for entry into this protocol) * AIDS based upon current Centers for Disease Control (CDC) definition (HIV testing is not required) PRIOR CONCURRENT THERAPY: * No prior systemic chemotherapy for the study cancer * Prior chemotherapy for a different cancer is permitted * No hormonal therapy initiated within the last 3 months * No prior radiotherapy to the pelvic region that would result in overlap of radiotherapy fields
References
Publications (0)
Data not yet available
No reference posted for this study.