Finding studies
Finding studies
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Lead
Rutgers, The State University of New Jersey
With
PRIMARY OBJECTIVES: I. To determine the effect of different doses of hydroxychloroquine on markers of autophagy in prostate tumor. SECONDARY OBJECTIVES: I. To determine the distribution of autophagic activity within prostate cancer tissue. II. To determine the utility of beclin-1 as a marker of autophagic activity. III. To assess markers of apoptosis in tumor tissue. IV. To perform deep-sequencing on prostate tissue obtained at the time of surgery. V. To assess prostate-specific antigen (PSA) as a biochemical endpoint of clinical activity. VI. To determine the number of circulating tumor cells (CTCs) in pre- and post-treatment blood samples. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I (PLANNING PROSTATECTOMY): Patients in Group I are randomized to 1 of 2 arms. ARM I: Patients receive hydroxychloroquine orally (PO) once daily (QD) for 14 days and then undergo prostatectomy. ARM II: Patients receive a higher dose of hydroxychloroquine PO thrice daily (TID) for 14 days and then undergo prostatectomy. GROUP II (ACTIVE SURVEILLANCE): Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
