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| ID | Type | Description | Link |
|---|---|---|---|
| Prostate Cancer Foundation | Other Identifier | Prostate Cancer Foundation |
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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
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The purpose of the study is to test genes for BRCAness(BRCA[BReast CAncer] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene signature may be able to predict response to satraplatin and a tool will be developed to be able to screen patients likely to benefit from satraplatin. Subjects will all receive Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered responders if they have measurable disease meeting criteria for partial or complete response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.
We will be developing a genomic based signature of "BRCAness" based on literature of genomic signatures from women with breast cancer and germline BRCA mutations.The "BRCAness" breast cancer signature will differentiate germline BRCA 1/2 breast cancers from standard estrogen-receptor (+) breast cancers. We will obtain a library of genomic signatures Recently these techniques have been used to develop a transcriptional "signature" for androgen receptor (AR) activity in men with CRPC(Castration Resistant Prostate Cancer). The investigator will apply the "BRCAness" breast cancer signature to pathological prostate cancer specimens to determine the percentage of patients in the overall prostate cancer population that express this signature, as well as the clinical and histological phenotype of this population.
This novel prostate cancer "BRCAness" signature will be developed over a period of 4-6 months. This "BRCAness" signature has not previously been evaluated in prostate cancer patients and would be expected, based on known characteristics of BRCA mutant breast and ovarian cancers, to be more platinum-responsive. Relevant clinical data, including histology, grade, stage, size of residual tumor, recurrence, and survival, will be obtained from outpatient and inpatient charts to perform subsequent correlative studies.
All patients enrolled in the phase II clinical trial with satraplatin will have pre-treatment biopsies of metastatic sites. All of the specimens will be frozen, batched and stored as previously described. We anticipate that all patients will be enrolled 16 months from when the trial opens. When the last patient is enrolled in the trial and all of the metastatic biopsies have been collected, they will be shipped in bulk on dry ice to laboratory for RNA(ribonucleic acid) isolation, RNA quality assessment and processing, microarray hybridization, microarray data quality assessment, and "BRCAness" prostate cancer signature application. Frozen biopsies will be processed for microarray analysis using laser capture microdissection and RNA amplification using adaptations of previously published methods. The application of the prostate cancer BRCAness signature will take place over two months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Satraplatin, Single Arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Satraplatin | Drug | Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Satraplatin as Second Line Therapy in Men With CRCP | Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days to Maximum Decline in PSA | Response rate - Maximum decline in PSA that occurs during treatment. | baseline and 3 months |
| Progression Free Survival (PFS) | Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression. |
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Inclusion Criteria:
Patients must have histologically confirmed adenocarcinoma of the prostate.
Radiographic evidence of metastatic disease (Bone scan, CT(Computerized Tomography) scan, or MRI(Magnetic Resonance Imaging) are acceptable) amenable to image-guided biopsy.
Castrate levels of testosterone (testosterone <50 ng/dL) on androgen deprivation therapy (ADT). LHRH(luteinizing hormone releasing hormone)agonist therapy must continue while on study unless patient has previously undergone an orchiectomy.
The patient must have discontinued antiandrogens (bicalutamide, flutamide or nilutamide) 30 days prior to baseline PSA.
Progression on at least one line of a prior docetaxel-based chemotherapy.
Patients must have adequate organ and marrow function as defined below:
Age > 18 years
Ability to take oral medications (pills must be swallowed whole)
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Ability to understand and the willingness to sign a written informed consent document
Patients must be willing to undergo an image-guided biopsy of a metastatic site on at least one occasion.
Patient agrees to utilize contraception while enrolled in the trial
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William K Oh, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
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Recruitment began in December 2010. Thirteen (13) patients from Mount Sinai Medical Center were enrolled to the study between January 27, 2011 and March 7, 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Satraplatin, Single Arm | Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Satraplatin, Single Arm | Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days |
| 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 | Efficacy of Satraplatin as Second Line Therapy in Men With CRCP | Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response. | Posted | Number | participants | 3 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 | Satraplatin, Single Arm | Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders |
limitation include low sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bobby Liaw | Icahn School of Medicine at Mount Sinai | (212) 604-6010 | bobby.liaw@mountsinai.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C081294 | satraplatin |
| C097758 | amminedichloro(cyclohexylamine)platinum(II) |
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| up to 2 years |
| Overall Survival | Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter. | 24 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Metastasis site | Number | participants |
|
| Gleason Score | Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors. Least-differentiated tumors typically have a worse prognosis. | Number | participants |
|
| PSA | pre-treatment PSA | Median | Full Range | ng/ml |
|
|
| Secondary | Number of Days to Maximum Decline in PSA | Response rate - Maximum decline in PSA that occurs during treatment. | Only responders included | Posted | Median | Full Range | days | baseline and 3 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression. | Posted | Median | Full Range | days | up to 2 years |
|
|
|
| Secondary | Overall Survival | Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter. | Posted | Median | Full Range | days | 24 months |
|
|
|
| 0 |
| 13 |
| 10 |
| 13 |
| Neutropenia | Blood and lymphatic system disorders |
|
| Thromboscytopenia | Blood and lymphatic system disorders |
|
| Fatigue | General disorders |
|
| Renal failure | Renal and urinary disorders |
|
| Dysphagia | General disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |