A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring Androderm®, Testosterone, refractory, prostate, cancer, Patients with "hormone refractory" prostate cancer will be treated with a daily testosterone patch Androderm® applied every 24 hours to the skin Read More

Inclusion Criteria:

• 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 Criteria:

• 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.