Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Pr… (NCT01251861) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
United States108 participantsStarted 2010-12-23
Plain-language summary
This phase II trial studies how well giving bicalutamide with or without Akt inhibitor MK2206 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bicalutamide is more effective with or without Akt inhibitor MK2206 in treating prostate cancer.
Who can participate
Age range18 Years
SexMALE
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Inclusion Criteria:
* Patient must have histologically confirmed diagnosis of prostate cancer
* Patient must have had previous treatment with definitive surgery or radiation therapy or cryoablation
* Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 4 weeks prior to randomization if the intent was for cure; prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
* Patient must have no evidence of metastatic disease on physical exam, computed tomography (CT) abdomen/pelvis (or magnetic resonance imaging \[MRI\]), chest x-ray (or CT chest) and bone scan within 8 weeks prior to randomization
* Patient may have had prior neoadjuvant and/or adjuvant therapy (chemotherapy, vaccines or experimental agents) within 4 weeks prior to randomization, if the PSA rise and PSA doubling time (PSADT) were documented after the testosterone level was \> 150 ng/dL
* Patient may not have had therapy modulating testosterone levels (such as luteinizing-hormone, releasing-hormone agonists/antagonists and antiandrogens) within 1 year prior to randomization, unless it was in the neoadjuvant and/or adjuvant setting; agents such as 5 alpha reductase inhibitors, ketoconazole, abiraterone, systemic steroids, or herbal supplements known to decrease PSA levels including any dose of megestrol acetate, finasteride (e.g., Saw Palmetto and PC-SPES, African pygeum extract, lycopene, alanine, glutamic acid and glycine, …
What they're measuring
1
The Proportion of Patients With Undetectable PSA Level (< 0.2 ng/mL) at 44 Weeks