This is a multicenter, randomized, phase II study of the safety and efficacy of two dose levels of oral ATN-224 in patients with prostate cancer with a rising serum PSA in the absence of detectable disease. Patients will be randomized (1:1) after confirmation of eligibility requirements. The primary endpoint is to determine the proportion of patients who do not have PSA progression for 24 weeks. PSA progression is defined as at least a 50% increase in PSA and \>5 ng/mL from baseline or post-treatment nadir if lower than baseline, confirmed by another PSA at least 28 days later.
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be anti-angiogenic and to have activity against prostate cancer cell lines. ATN-224 has the potential to affect the progression of prostate cancer by mechanisms that include both antiangiogenic and antitumor pathways. ATN-224 may change the time to overt metastatic disease in patients with rising PSA as the only manifestation of disease after treatment with curative intent and delay the need for hormonal therapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ATN-224 high dose: 300mg ATN-224 low dose: 30mg
University of California San Francisco
San Francisco, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Determine the proportion of patients who have not had prostate specific antigen (PSA) progression for 24 weeks
Time frame: 24 weeks
Establish the safety of the two dose levels of ATN-224
Time frame: Ongoing
Determine the proportion of patients with a 50% reduction from baseline of PSA confirmed by a second PSA value at least 28 days later
Time frame: End of Study
Determine the change in PSA doubling time (PSA-DT) from baseline
Time frame: End of Study
Determine the maximal % decrease in PSA after treatment
Time frame: End of Study
Determine the time to PSA progression (as defined by this protocol)
Time frame: End of Study
Determine the 24-week rate of metastases
Time frame: 24 weeks
Determine the effect of ATN-224 treatment on levels of Cu,Zn-superoxide dismutase (SOD1) in red blood cells
Time frame: End of Study
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States