The primary objectives of the study are: * To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at 5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of biochemical relapse (M0) following local treatment (i.e., surgery or radiation). * To assess the rate of PSA (prostatic specific antigen) progression at 6 months after treatment with 5mg/day and 25mg/day of Revlimid (CC-5013) in patients with evidence of biochemical relapse after local therapy. The secondary objectives of the study are: * To provide preliminary assessments on the effects of Revlimid (CC-5013) at 5mg/day and 25mg/day on various PSA constructs in the subject population (i.e., PSADT \[Prostatic Specific Antigen Doubling Time\] and PSA slope) by comparing pre and post treatment patterns in each arm. * To evaluate preliminary pharmacodynamic correlations between serum revlimid concentrations and toxicity, PSA constructs and other evidence of disease progression.
Carcinoma of the prostate in the most commonly diagnosed malignancy among men in this country with approximately 232,090 new cases expected to be diagnosed in 2005. Unfortunately, despite local treatment, many men will demonstrate evidence of PSA recurrence. At the present time, there is no standard treatment fo these patients. The management of patients with PSA recurrence remains greatly controversial. Androgen deprivation is frequently employed in patients with evidence of rising PSA levels despite the fact that the effects on quantity and quality of life of androgen deprivation therapy at this stage, remains un-established. Toxicity of androgen deprivation therapy is a major factor to be considered in the decision process of employing the modality of treatment in patients with no symptoms associated with this disease. Because patients with biochemical relapse are mostly asymptomatic and typically have long survivals and disease free survivals, mush of the focus of new drug development has been with the use of non-cytotoxic compounds. This study is intended to provide preliminary evidence of a biological effect in a dose response manner assessing the effects of Revlimid (CC-5013) on PSA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
one 5 mg/day capsule or one 25 mg/day capsule with matched placebo capsule day 1-21 (28 day cycle)
The Harry and Jeanette Weinberg Building
Baltimore, Maryland, United States
Safety, Feasibility and Tolerance of Revlimid as Assessed by Number of Participants Experiencing Grade 3 and 4 Adverse Events.
Number of participants experiencing Grade 3 and 4 adverse events as defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Time frame: 6 months post-intervention
Number of Participants With Prostate-specific Antigen (PSA) Progression
Number of participants with greater than or equal to 25% increase in PSA at 6 months
Time frame: 6 months post-intervention
Change in of PSA Slope
Mean change in PSA slope from baseline to 6 months. PSA slope was calculated using the regression of log PSA over 6 months in each patient. A negative mean change in PSA slope reflects a better outcome.
Time frame: Change from baseline to 6 months post-intervention
Plasma Concentration of Revilimid at Steady State
Mean plasma concentration (ng/mL) of Revilimid at steady state (Day 21 of second treatment cycle)
Time frame: Day 21 of second treatment cycle
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