Prostate Cancer Clinical Trial

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

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.

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Full Description

OBJECTIVES:

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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

67

Study ID:

NCT00551525

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 29 Locations for this study

See Locations Near You

Arizona Oncology Services Foundation
Phoenix Arizona, 85013, United States
Auburn Radiation Oncology
Auburn California, 95603, United States
Radiation Oncology Centers - Cameron Park
Cameron Park California, 95682, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael California, 95608, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles California, 90027, United States
Radiation Oncology Center - Roseville
Roseville California, 95661, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento California, 95815, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
Mercy General Hospital
Sacramento California, 95819, United States
Solano Radiation Oncology Center
Vacaville California, 95687, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
John B. Amos Cancer Center
Columbus Georgia, 31904, United States
Tulane Cancer Center Office of Clinical Research
Alexandria Louisiana, 71315, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River Massachusetts, 02721, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Regional Cancer Center at Singing River Hospital
Pascagoula Mississippi, 39581, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis Missouri, 63141, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Barberton Citizens Hospital
Barberton Ohio, 44203, United States
Robinson Radiation Oncology
Ravenna Ohio, 44266, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States
Coastal Cancer Center at Sentara Virginia Beach General Hospital
Virginia Beach Virginia, 23454, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

67

Study ID:

NCT00551525

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

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