Status:
COMPLETED
A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer
Lead Sponsor:
University of Chicago
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal ...
Detailed Description
Most hormone-refractory disease is currently defined by rising PSA following androgen ablation and an antiandrogen. These patients are typically asymptomatic and have minimal or no radiologically evid...
Eligibility Criteria
Inclusion
- Patient has a histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative treatment with surgery or radiation treatment.
- Patient was surgically or pharmacologically castrated at least 6 months prior to randomization. Castration must be verified by a screening testosterone value of \<30 ng/dL. Any patient pharmacologically castrated must be maintained on androgen suppression therapy for the duration of the study.
- Patient must have had a previous trial of anti-androgen therapy.
- Patients must have a documented anti-androgen withdrawal period prior to randomization: flutamide requires a minimum 4 weeks withdrawal, and nilutamide and bicalutamide require a minimum 6 weeks withdrawal.
- Patient must meet one of the following PSA criteria:
- A 50% rise in PSA values within a minimum rise to at least 3.0 ng/mL, within 6 months prior to randomization, OR
- A rising PSA defined as two sequential increases in PSA values. The following data are required: an initial value (#1) followed by a PSA value demonstrating an increase (#2). The increase must be confirmed by another rise in PSA (#3) (3\>2\>1). There must be at least 2 weeks between each qualifying PSA value and the absolute PSA value at enrollment must be at least 3.0 ng/ml.
- At the time of screening the patient must have no evidence of visceral organ-confined metastatic disease OR the presence of minimal bone metastases only without evidence of visceral organ-confined metastatic disease.
- The absence of visceral organ-confined metastatic disease is defined as:
- No organ-confined soft tissue metastases (e.g. lung, liver, etc.) as verified by chest/abdomen/pelvic CT scan.
- The presence of pathologically enlarged lymph nodes will not exclude subjects from the study and will not be included in the definition of visceral organ-confined metastatic disease.
- The presence of minimal bone metastases is defined as \<1.4% by Bone Scan Index criteria (see section 9).
- ECOG performance status \<2 (Karnofsky \>70%, see Appendix A).
- Age \>18 years. Because no dosing or adverse event data are currently available on the use of Androderm® in the context of androgen ablation in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
- Patients must have normal hepatic and renal function as defined below:
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \<1.5 X institutional upper limit of normal
- Patient has had no other active malignancies with the exception of non-melanoma skin cancer.
- Patient must possess the ability to understand and be willing to sign a written informed consent document.
Exclusion
- Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium).
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with evidence of visceral organ-confined metastases other than minimal bone metastases (as defined by \<1.4% Bone Scan Index, see section 9) and/or pathologically enlarged lymph nodes will be excluded.
- Patients with local recurrences who are candidates for local salvage therapy (e.g. surgery, radiation, brachytherapy, cryotherapy) will be excluded.
- Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded. Steroid therapy for non-pulmonary, non-oncologic conditions are allowed if the patient has been on a chronic, steady-dose regimen for a minimum of 2 months prior to randomization.
- Patients with known skin allergies to polyester, alcohol, aluminum, or silicone.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01187485
Start Date
June 1 2004
End Date
February 1 2009
Last Update
November 29 2023
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637