| Original Study ID : CDR0000570622 |
| Secondary ID : RTOG-0622 |
| NCT ID : NCT00551525 |
| Brief Title : 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 |
| Official Title : A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3DCRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy |
| Brief 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. |
| Source : National Cancer Institute (NCI) |
| Detailed 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 concurrent hormonal therapy (at the start of 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 at 3 months, 6 months, and 12 months, every 6 months for 2 years, and then annually thereafter. |
| Overall Status : Recruiting |
| Start Date : April 2008 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Enrollment : 76 |
| Verification Date : May 2009 |
| First Received Date : October 30, 2007 |
| Trial 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 2.0 ng/mL - Postoperative PSA rising above 0.2 ng/mL with a surgical tumor Gleason score of 9 or 10 - Rapidly rising PSA profile with a doubling time of less than 6 months - 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 - 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 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 |
| Gender : Male |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Enloe Cancer Center at Enloe Medical Center |
| Status : Recruiting |
| City : Chico |
| State : California |
| Zip Code : 95926 |
| Country : United States |
| Facility Name : CCOP - Christiana Care Health Services |
| Status : Recruiting |
| City : Newark |
| State : Delaware |
| Zip Code : 19713 |
| Country : United States |
| Facility Name : Baptist Cancer Institute - Jacksonville |
| Status : Recruiting |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32207 |
| Country : United States |
| Facility Name : Baptist Medical Center South |
| Status : Recruiting |
| City : Jascksonville |
| State : Florida |
| Zip Code : 32258 |
| Country : United States |
| Facility Name : Flagler Cancer Center |
| Status : Recruiting |
| City : Saint Augustine |
| State : Florida |
| Zip Code : 32086 |
| Country : United States |
| Facility Name : Florida Cancer Center - Palatka |
| Status : Recruiting |
| City : Palatka |
| State : Florida |
| Zip Code : 32177 |
| Country : United States |
| Facility Name : Integrated Community Oncology Network - Orange Park |
| Status : Recruiting |
| City : Orange Park |
| State : Florida |
| Zip Code : 32073 |
| Country : United States |
| Facility Name : Integrated Community Oncology Network at Southside Cancer Center |
| Status : Recruiting |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32207 |
| Country : United States |
| Facility Name : Integrated Community Oncology Network |
| Status : Recruiting |
| City : Jacksonville Beach |
| State : Florida |
| Zip Code : 32250 |
| Country : United States |
| Facility Name : University of Florida Shands Cancer Center |
| Status : Recruiting |
| City : Gainesville |
| State : Florida |
| Zip Code : 32610-0232 |
| Country : United States |
| Facility Name : CCOP - Carle Cancer Center |
| Status : Recruiting |
| City : Urbana |
| State : Illinois |
| Zip Code : 61801 |
| Country : United States |
| Facility Name : Tulane Cancer Center Office of Clinical Research |
| Status : Recruiting |
| City : Alexandria |
| State : Louisiana |
| Zip Code : 71315-3198 |
| Country : United States |
| Facility Name : Hudner Oncology Center at Saint Anne's Hospital - Fall River |
| Status : Recruiting |
| City : Fall River |
| State : Massachusetts |
| Zip Code : 02721 |
| Country : United States |
| Facility Name : Barberton Citizens Hospital |
| Status : Recruiting |
| City : Barberton |
| State : Ohio |
| Zip Code : 44203 |
| Country : United States |
| Facility Name : Cancer Treatment Center |
| Status : Recruiting |
| City : Wooster |
| State : Ohio |
| Zip Code : 44691 |
| Country : United States |
| Facility Name : Charles F. Kettering Memorial Hospital |
| Status : Recruiting |
| City : Kettering |
| State : Ohio |
| Zip Code : 45429 |
| Country : United States |
| Facility Name : Middletown Regional Hospital |
| Status : Recruiting |
| City : Franklin |
| State : Ohio |
| Zip Code : 45005-1066 |
| Country : United States |
| Facility Name : Summa Center for Cancer Care at Akron City Hospital |
| Status : Recruiting |
| City : Akron |
| State : Ohio |
| Zip Code : 44309-2090 |
| Country : United States |
| Facility Name : Oklahoma University Cancer Institute |
| Status : Recruiting |
| City : Oklahoma City |
| State : Oklahoma |
| Zip Code : 73104 |
| Country : United States |
| Facility Name : Kimmel Cancer Center at Thomas Jefferson University - Philadelphia |
| Status : Recruiting |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19107-5541 |
| Country : United States |
| Facility Name : Mercy Hospital Cancer Center - Scranton |
| Status : Recruiting |
| City : Scranton |
| State : Pennsylvania |
| Zip Code : 18501 |
| Country : United States |
| Facility Name : Sentara Cancer Institute at Sentara Norfolk General Hospital |
| Status : Recruiting |
| City : Norfolk |
| State : Virginia |
| Zip Code : 23507 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Disease response |
| Safety issue : No |
| Secondary OutComes |
| Measure : Completion of therapy |
| Safety issue : No |
| Measure : Hematologic toxicity at 12 weeks |
| Safety issue : Yes |
| Measure : Samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks |
| Safety issue : Yes |
| Measure : Acute and late radiotherapy-related adverse events at 24 weeks |
| Safety issue : Yes |
| Measure : Compare the freedom from progression rate at 2 years with that predicted by the Kattan Nomograms |
| Safety issue : No |
| Interventions |
| Type : Radiation |
| Name : 3-dimensional conformal radiation therapy |
| Type : Radiation |
| Name : intensity-modulated radiation therapy |
| Type : Radiation |
| Name : samarium Sm 153 lexidronam pentasodium |
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