Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2017 |
| Start Date: | July 2012 |
| End Date: | February 26, 2016 |
Assessment of the Biological Effect of Autophagic Inhibition With Hydroxychloroquine in Prostate Cancer
This phase 0 trial studies hydroxychloroquine in blocking autophagy in patients with
prostate cancer who are undergoing surgery or active surveillance. Autophagy is a process in
which cells break down some parts of themselves to stay alive during times of stress, such
as starvation. This may allow cancer cells to survive damage from chemotherapy.
Hydroxychloroquine may block this process from happening.
prostate cancer who are undergoing surgery or active surveillance. Autophagy is a process in
which cells break down some parts of themselves to stay alive during times of stress, such
as starvation. This may allow cancer cells to survive damage from chemotherapy.
Hydroxychloroquine may block this process from happening.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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