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
NCT ID: NCT00551525
Last Updated: 2017-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2008-04-30
2016-12-31
Brief Summary
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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.
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Detailed Description
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Primary
* To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional conformal radiation therapy or intensity-modulated radiation therapy in patients with rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate cancer.
Secondary
* To assess the proportion of patients completing protocol treatment.
* To evaluate hematological toxicity at 12 weeks.
* To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
* To evaluate the "acute" and "late" radiation therapy-related events having occurred up to 24 weeks from the end of radiation therapy.
* To compare the freedom from progression rate at 2 years to that predicted by the Kattan Nomograms.
OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients may receive hormonal therapy (after radiation therapy) at the discretion of their physician.
Treatment continues in the absence of disease progression (defined as a PSA doubling time less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000 cells/mm³ or less), or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy + Samarium 153
Samarium 153 infusion followed by radiotherapy 12 weeks later
Radiotherapy
3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.
Samarium 153
Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
Interventions
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Radiotherapy
3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.
Samarium 153
Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Presence of neuroendocrine features in any prostate cancer specimen
PATIENT CHARACTERISTICS:
* 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
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Richard K. Valicenti, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Cancer Center at Thomas Jefferson University
Oliver Sartor, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Auburn Radiation Oncology
Auburn, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Billings Clinic - Downtown
Billings, Montana, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Robinson Radiation Oncology
Ravenna, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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CDR0000570622
Identifier Type: -
Identifier Source: secondary_id
NCI-2009-01094
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG-0622
Identifier Type: -
Identifier Source: org_study_id
NCT01317043
Identifier Type: -
Identifier Source: nct_alias
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