Phase 2
Completed N=67
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
Source: ClinicalTrials.gov NCT00551525 ↗Enrolled (actual)
67
Serious AEs
8.3%
Results posted
Jul 2017
Primary outcomePrimary: Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration — 7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration |
7 | — |
| SECONDARY Completion of Therapy |
93.3 | <0.001 sig |
| SECONDARY Number of Patients With Hematologic Toxicity at 12 Weeks |
15 | — |
| SECONDARY Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients) |
16 | — |
| SECONDARY Acute and Late Radiotherapy-Related Adverse Events |
35; 27 | — |
| SECONDARY Freedom From Progression (FFP) Rate at 2 Years |
25.50 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00551525). 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.