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| ID | Type | Description | Link |
|---|---|---|---|
| 96025 | Other Identifier | Stanford University alternate IRB Number | |
| PROS0010 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulvestrant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| PSA Reduction ≥ 50% | Number of subjects with serum PSA reduction ≥ 50% at 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Doubling Time | Number of subjects with prolongation of PSA doubling time | 3 months |
| Stable Disease After One Year | Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Sandy Srinivas | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Srinivas S, Harshman LC, Feldman D. "Effect of fulvestrant on PSA doubling time in patients with castration-resistant prostate cancer (CRPC)." JCO. Annual Meeting, ASCO 2010. 20 May 2010;28(15-suppl)(abs e15112). |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant 250 mg | IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants were included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant 250 mg | IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | PSA Reduction ≥ 50% | Number of subjects with serum PSA reduction ≥ 50% at 3 months | All subjects (10 males) had castration-resistant prostate cancer. 6 had recieved prior radical prostatectomy as primary therapy. 4 had received prior chemotherapy. The majority had previously received 2 hormonal therapies. 2 had recieved radiation therapy, and 2 had recieved hormonal monotherapy. | Posted | Number | participants | 3 months |
|
|
12 months
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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 | Fulvestrant 250 mg | IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor of Medicine (Oncology) | Stanford University Medical Center | 650-725-2078 | sandysri@stanford.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 |
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| 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | PSA Doubling Time | Number of subjects with prolongation of PSA doubling time | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Stable Disease After One Year | Stable disease was defined as continuing treatment without disease progression, with disease progression defined as 3 consecutive rises in serum PSA or objective progression by RECIST criteria. | Posted | Number | participants | 12 months |
|
|
|
| 3 |
| 10 |
| 0 |
| 10 |
| Skin and subcutaneous tissue disorders - Edema | Skin and subcutaneous tissue disorders | CTCAE (4.0) |
|
| Skin and subcutaneous tissue disorders - Intermittent tiny sensitive area on forehead (sligh | Skin and subcutaneous tissue disorders | CTCAE (4.0) |
|
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |