Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rutgers, The State University of New Jersey
With
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
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
You may be eligible if
Signed written informed consent
Have abnormal digital rectal examination, or abnormal prostate specific antigen (\> 4.0 ng/ml), or obstructing prostate, or biopsy proven prostate cancer
Scheduled for prostate surgery, i.e. transurethral resection of the prostate (TURP) or prostatectomy
Planned to be treated by active surveillance
You may not be if
Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
Patients with psoriasis
Patients receiving any disease-modifying anti-rheumatic drug (DMARD)
Active clinically significant infection requiring antibiotics
Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy, which are calcitriol and chloroquine
Patients taking medications which may lead to interactions with hydroxychloroquine, including penicillamine, telbivudine, botulinum toxin, digoxin, and propafenone
Patients must not have prior visual field changes from prior 4-aminoquinoline compound use
Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria
History of hypersensitivity to 4-aminoquinoline compound
Clareo Health | Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance
