Phase I/II Double Blinded Randomized Study to Determine the Tolerability and Efficacy of 2 Different Doses of Revlimid (CC-5013, Lenalidomide) in Biochemically Relapsed Prostate Cancer Patients (M0) After Local Treatment
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study feasibility, safety, tolerance, rate of PSA PD of Revlimid at 6 months.
Mario A Eisenberger, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
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