| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000570622 | |||
| NCI-2009-01094 | Registry Identifier | CTRP(Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + Samarium 153 | Experimental | Samarium 153 infusion followed by radiotherapy 12 weeks later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration | 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. | Twelve weeks from the date of Samarium 153 infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Therapy | The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint. |
Not provided
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically proven diagnosis of prostate cancer progressing after prior radical prostatectomy as indicated by one of the following:
Stage II-IV disease (T2 -T4, N0-N1)
No distant metastases based on the following minimum diagnostic work up:
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years
Severe, active comorbidity, defined as follows:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for the study cancer
No hormonal therapy initiated within the last 3 months
No prior radiotherapy to the pelvic region that would result in overlap of radiotherapy fields
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard K. Valicenti, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Oliver Sartor, MD | Dana-Farber Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | United States | ||
| Auburn Radiation Oncology |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiotherapy + Samarium 153 | Samarium 153 infusion followed by radiotherapy 12 weeks later |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Samarium 153 | Drug | Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration. |
|
|
| 90 days from the end of radiation therapy. |
| Number of Patients With Hematologic Toxicity at 12 Weeks | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's. | Twelve weeks from the date of Samarium 153 infusion. |
| Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients) | Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:
| Twelve weeks from the date of Samarium 153 infusion |
| Acute and Late Radiotherapy-Related Adverse Events | The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed. | 90 days from start of radiotherapy |
| Freedom From Progression (FFP) Rate at 2 Years | Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See "Limitations and Caveats" section. | From randomization to 2 years |
| 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 | 32610-0232 | United States |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | United States |
| Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River | Massachusetts | 02721 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Stony Brook University Cancer Center | Stony Brook | New York | 11794-9446 | 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 | 44309-2090 | 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 | 19107-5541 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiotherapy + Samarium 153 | Samarium 153 infusion followed by radiotherapy 12 weeks later |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration | 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. | All eligible patients who received Samarium 153 with at least 12 weeks follow-up from the injection | Posted | Number | percentage of participants | Twelve weeks from the date of Samarium 153 infusion. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Completion of Therapy | The completion of protocol treatment is defined as receiving at least 64.8 Gy radiation after the Samarium 153 injection. The null hypothesis that the proportion of the number of patients who complete the protocol treatment (the Samarium 153 and the radiation therapy) is less than or equal to 0.5 was tested using an exact test for a binomial proportion. If the true treatment completion proportion is 0.8, then the statistical power of a one-sided 0.378 level exact binomial test of proportion would be 94.1% with the sample size of 26. Therefore any number of analyzable patients greater than 26 patients provides enough power for this endpoint. | All eligible patients who started treatment and did not withdraw consent prior to 90 days from the end of radiation therapy | Posted | Number | 95% Confidence Interval | percentage of participants | 90 days from the end of radiation therapy. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Hematologic Toxicity at 12 Weeks | Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Hematological toxicities consist of platelet grade 3-5, white blood cell grade 3-5, hemoglobin grade 3-5, and any secondary leukemia's. | Eligible patients who started study treatment | Posted | Count of Participants | Participants | Twelve weeks from the date of Samarium 153 infusion. |
|
| |||||||||||||||||||||||||||
| Secondary | Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients) | Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. The treatment-related attribution includes definitely, probably or possibly related to treatment. The treatment-related adverse events are:
| Eligible patients with adverse event data | Posted | Number | percentage of participants | Twelve weeks from the date of Samarium 153 infusion |
|
| |||||||||||||||||||||||||||
| Secondary | Acute and Late Radiotherapy-Related Adverse Events | The number of patients who experienced a grade 1-5 radiation-related adverse events within 90 days of the start of radiotherapy (acute) and after 90 days (late). Adverse events are evaluated by the NCI Common Terminology Criteria for Adverse Event (CTCAE) version 3.0. Multivariate logistic regression was used to model the association of clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age with the occurrence of any acute radiotherapy-related adverse event. Odds ratios and the respective 95% confidence intervals were computed for each factor. Per the protocol, late adverse events were not analyzed. | Eligible patients with adverse event data | Posted | Number | participants | 90 days from start of radiotherapy |
|
| |||||||||||||||||||||||||||
| Secondary | Freedom From Progression (FFP) Rate at 2 Years | Progression is defined as biochemical (PSA) failure at any time for 2 years after prostatic fossa radiation therapy (RT), initiation of systemic therapy, or clinical failure. Biochemical failure is defined as a rise of 0.2 ng/ml or more above the nadir PSA after completion of RT followed by another higher value, or a continued rise in the serum PSA despite RT. FFP rate at 2 years was to be compared to that predicted by the Kattan Nomograms. See "Limitations and Caveats" section. | Eligible patients who started study treatment | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to 2 years |
|
|
Not provided
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event. Eligible patients with any adverse event data are included.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiotherapy + Samarium 153 | Samarium 153 infusion followed by radiotherapy 12 weeks later | 5 | 60 | 55 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain [other] | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Comparison of freedom from progression rate at two years with Kattan Nomograms was not possible because the pretreatment data needed for the Kattan Nomograms was not collected.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld, M.S. | NRG Oncology | seiferheldw@nrgoncology.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| C000615023 | Samarium-153 |
| C061972 | samarium Sm-153 lexidronam |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011881 | Radiotherapy, Computer-Assisted |
Not provided
Not provided
|
|
|
|
|
|
|