Prostate, Cancer, Hormonal Cycling
Conditions
Keywords
Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE, ZOLADEX
Brief summary
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
Interventions
DRUGGnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
DRUGKetoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
DRUGBicalutamide
A pure nonsteroidal antiandrogen
DRUGTestosterone transdermal gel
an androgenic anabolic steroid
DRUGEstrogen transdermal patch
Estradiol is the primary and most potent estrogen
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months. 2. One cycle of intermittent therapy up to a maximum exposure of 10 months. * 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
* Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease. * Uncontrolled serious active infection. * Anticipated survival of less than 3 months. * Active CNS or epiduraltumor * Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Evaluable for Toxicity Only | 5 |
| Overall Study | Patiemt Non-compliance | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 36 |
| serious Total, serious adverse events | 2 / 36 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Response | Complete Response (CR) | 22 participants |
| All Participants | Response | Partial Response (PR) | 4 participants |
| All Participants | Response | Stable Disease (SD) | 3 participants |