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| ID | Type | Description | Link |
|---|---|---|---|
| 2001-114 | Other Identifier | CCRRC | |
| JT 1013 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Cytogen Corporation | INDUSTRY |
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The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.
The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.
The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samarium-153 (0.25 mCi/kg) | Experimental | Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
| Samarium-153 (0.5 mCi/kg) | Experimental | Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
| Samarium-153 (0.75 mCi/kg) | Experimental | Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
| Samarium-153 (1.0 mCi/kg) | Experimental | Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samarium-153 | Drug | Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Samarium-153 | To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose. | 5 months (1 month HT, administration of drug, 4 months HT and RT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edouard Trabulsi, MD | Thomas Jefferson University | Principal Investigator |
| Richard Valicenti, MD, MA | UC Davis School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
| Thomas Jefferson University Hospitals | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Samarium-153 (0.25 mCi/kg) | Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| FG001 | Samarium-153 (0.5 mCi/kg) | Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Samarium-153 (1.5 mCi/kg) | Experimental | Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
| Samarium-153 (2.0 mCi/kg) | Experimental | Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
|
|
| Total Androgen Suppression (TAS) with Bicalutamide | Drug | Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. |
|
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| Total androgen suppression (TAS) with Goserelin Acetate | Drug | Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. |
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| Radiation Therapy | Device | Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks. |
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| FG002 | Samarium-153 (0.75 mCi/kg) | Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| FG003 | Samarium-153 (1.0 mCi/kg) | Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| FG004 | Samarium-153 (1.5 mCi/kg) | Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| FG005 | Samarium-153 (2.0 mCi/kg) | Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Samarium-153 (0.25 mCi/kg) | Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG001 | Samarium-153 (0.5 mCi/kg) | Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG002 | Samarium-153 (0.75 mCi/kg) | Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG003 | Samarium-153 (1.0 mCi/kg) | Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG004 | Samarium-153 (1.5 mCi/kg) | Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG005 | Samarium-153 (2.0 mCi/kg) | Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Maximum Tolerated Dose of Samarium-153 | To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose. | Posted | Number | mCi/kg | 5 months (1 month HT, administration of drug, 4 months HT and RT) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Samarium-153 (0.25 mCi/kg) | Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 0 | 4 | 0 | 4 | ||
| EG001 | Samarium-153 (0.5 mCi/kg) | Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 1 | 4 | 0 | 4 | ||
| EG002 | Samarium-153 (0.75 mCi/kg) | Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 1 | 6 | 0 | 6 | ||
| EG003 | Samarium-153 (1.0 mCi/kg) | Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 2 | 5 | 0 | 5 | ||
| EG004 | Samarium-153 (1.5 mCi/kg) | Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 3 | 5 | 0 | 5 | ||
| EG005 | Samarium-153 (2.0 mCi/kg) | Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy | 5 | 6 | 0 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Hemoglobin | Blood and lymphatic system disorders |
| |||
| Blood/bone marrow | Blood and lymphatic system disorders |
| |||
| Platelet count decreased | Blood and lymphatic system disorders |
| |||
| Urinary frequency/urgency | Renal and urinary disorders |
| |||
| Proctitis | Gastrointestinal disorders |
| |||
| Libido decreased | General disorders |
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| Urine color changed | Renal and urinary disorders |
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| Dehydration | General disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Hemorrhoids | Gastrointestinal disorders |
| |||
| Erythema multiforme | Skin and subcutaneous tissue disorders |
| |||
| Abdominal pain and cramping | General disorders |
| |||
| Hot flashes/flushes | General disorders |
| |||
| Urinary incontinence | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edouard Trabulsi, MD | Thomas Jefferson University | 215-955-1000 | Edouard.Trabulsi@jefferson.edu |
| 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 |
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| ID | Term |
|---|---|
| C000615023 | Samarium-153 |
| C061972 | samarium Sm-153 lexidronam |
| C065339 | 3,5-tetrahydroaldosterone sulfate |
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|