Prostate Cancer
Conditions
Keywords
prostate cancer
Brief summary
Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.
Interventions
application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study. The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
Sponsors
National Cancer Institute (NCI)
University of Medicine and Dentistry of New Jersey
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 with metastatic prostate adenocarcinoma, who have failed initial hormone therapy and who have had progression after at least one chemotherapy regimen that included docetaxel. Patients on antiandrogens must have progression after withdrawal of the antiandrogen for 4 weeks (flutamide) or 6 weeks (bicalutamide). * PSA ≥ 10 ng/ml. * Patients who have received LHRH agonist therapy for \> 1 month must maintain agonist therapy while on-study. Patients who have not received agonist therapy or received \< 1 month of therapy, may not begin or continue agonist therapy while on-study. * Age \>18 years and an estimated life expectancy of at least 4 months. * ECOG performance status ≤ 2 (see Appendix B). * Full recovery from the effects of any prior surgery or radiation therapy within 4 weeks of study entry. * Serum creatinine ≤ 1.5 x ULN * Total bilirubin \< ULN * Transaminases (SGOT and/or SGPT) ≤ 2 X institutional upper limit. * Capacity to give informed, written consent.
Exclusion criteria
* Any coexisting medical condition precluding full compliance with the study. * Any history of deep venous thrombosis (DVT) or pulmonary embolus. Patients with a DVT on anticoagulants for ≥ 6 months will be eligible. * Known CNS metastasis. * The discontinuation of flutamide or bicalutamide \< 4 or 6 weeks respectively. * History of severe cardiovascular disease (AHA class III or IV; see Appendix C), uncontrolled CHF or life threatening cardiac dysrhythmia in the past 6 months. * Herbal supplements may not be used while on-study and patients must have discontinued use for ≥ 1 week before entering on-study. * Patients with a known hypersensitivity to estrogen. * Triglyceride \> 200 mg/dl. * Prior estramustine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With PSA Response | 3 years | PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention. |
Secondary
| Measure | Time frame |
|---|---|
| To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P). | 3 years |
| Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer | 4 years |
| Time to Progression | 3 years |
| Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch | 3 years |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 community hospitals within the Cancer Institute of New Jersey Oncology Group from May 2005 through April 2008.
Participants by arm
| Arm | Count |
|---|---|
| Transdermal Estradiol Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Transdermal Estradiol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 72.4 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 23 |
| serious Total, serious adverse events | 5 / 23 |
Outcome results
Primary
Percentage of Patients With PSA Response
PSA Response is a critical outcome measure used to assess the efficacy of treatments for conditions such as prostate cancer. PSA, or Prostate-Specific Antigen. The PSA Response is a measure of the change in PSA levels before and after a specific treatment intervention.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transdermal Estradiol | Percentage of Patients With PSA Response | 8.7 percentage of participants |
Secondary
Measurable Disease Response Assessment in Participants With Hormone and Chemotherapy Refractory Prostate Cancer
Time frame: 4 years
Population: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Secondary
Plateau Level of Estradiol and Testosterone Response in Androgen-Resistant Population With 0.4mg/Day Transdermal Estradiol Patch
Time frame: 3 years
Population: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Secondary
Time to Progression
Time frame: 3 years
Population: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate
Secondary
To Measure Quality of Life of Participants Receiving Therapy With the Functional Assessment of Cancer Therapy-Prostate Scale (FACT-P).
Time frame: 3 years
Population: Outcome Measure was pre-specified to be assessed based on achieving a certain pre-requisite response rate