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Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH | Drug | leuprolide and goserelin are gonadotropin-releasing hormone analogues |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response | Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable. | 6 months |
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Inclusion Criteria:
-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.
B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%
Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.
Patient must have level of serum testosterone above the lower limit of normal.
Karnofskcy performance status (KPS) >_70%.
Patients must have adequate organ function as defined by the following laboratory criteria:
WBC >_3500/mm3, platelet count >_100,000/mm3.
Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.
Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.
Prior hormonal therapy is allowed as:
Patients must be at least 18 years of age.
Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Scher, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer |
| 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 |
| 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 | Response | Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable. | Posted | Number | participants | 6 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 | All Participants | Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Howard Scher | Memorial Sloan Kettering Cancer Center | 646-422-4323 | Scherh@mskcc.org |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D017273 | Goserelin |
| D007654 | Ketoconazole |
| C053541 | bicalutamide |
| D013739 | Testosterone |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Ketoconazole | Drug | An imidazole antifungal agent. reduces adrenal and testicular androgen production in men |
|
|
| Bicalutamide | Drug | A pure nonsteroidal antiandrogen |
|
|
| Testosterone transdermal gel | Drug | an androgenic anabolic steroid |
|
|
| Estrogen transdermal patch | Drug | Estradiol is the primary and most potent estrogen |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 2 |
| 36 |
| 20 |
| 36 |
| Cardiovascular, other | Cardiac disorders | CTC-2.0 | Systematic Assessment |
|
| Hot Flashes | General disorders | CTC-2.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
|
| SGPT (ALT) | Metabolism and nutrition disorders | CTC-2.0 | Systematic Assessment |
|
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| 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 |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045166 | Estradiol Congeners |