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Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance

Primary Purpose

Prostate Carcinoma

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Laboratory Biomarker Analysis
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I, Arm I (lower dose hydroxychloroquine)

Group I, Arm II (higher dose hydroxychloroquine)

Group II (mid-dose hydroxychloroquine)

Arm Description

Patients receive hydroxychloroquine PO QD for 14 days and then undergo prostatectomy.

Patients receive hydroxychloroquine PO TID for 14 days and then undergo prostatectomy.

Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.

Outcomes

Primary Outcome Measures

Change in markers of autophagy in prostate tumor (Group I)
Levels of markers of autophagy in prostate tumor (Group II)

Secondary Outcome Measures

Distribution of autophagic activity in prostate cancer tissue
Autophagic activity, assessed by beclin-1 levels
The utility of beclin-1 as a marker of autophagic activity will be determined.
Levels of markers of apoptosis in tumor tissue
Clinical activity, as assessed by PSA levels
Number of CTCs in blood samples
The number of CTCs in pre- and post-treatment blood samples will be determined.

Full Information

First Posted
December 10, 2014
Last Updated
February 1, 2017
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02421575
Brief Title
Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance
Official Title
Assessment of the Biological Effect of Autophagic Inhibition With Hydroxychloroquine in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 26, 2016 (Actual)
Study Completion Date
February 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I, Arm I (lower dose hydroxychloroquine)
Arm Type
Experimental
Arm Description
Patients receive hydroxychloroquine PO QD for 14 days and then undergo prostatectomy.
Arm Title
Group I, Arm II (higher dose hydroxychloroquine)
Arm Type
Experimental
Arm Description
Patients receive hydroxychloroquine PO TID for 14 days and then undergo prostatectomy.
Arm Title
Group II (mid-dose hydroxychloroquine)
Arm Type
Experimental
Arm Description
Patients receive hydroxychloroquine PO QD. Treatment continues until the beginning of local therapy or for up to 1 year.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
HCQ
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in markers of autophagy in prostate tumor (Group I)
Time Frame
Baseline to 14 days (time of surgery)
Title
Levels of markers of autophagy in prostate tumor (Group II)
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Distribution of autophagic activity in prostate cancer tissue
Time Frame
Up to 1 year
Title
Autophagic activity, assessed by beclin-1 levels
Description
The utility of beclin-1 as a marker of autophagic activity will be determined.
Time Frame
Up to 1 year
Title
Levels of markers of apoptosis in tumor tissue
Time Frame
Up to 1 year
Title
Clinical activity, as assessed by PSA levels
Time Frame
Up to 1 year
Title
Number of CTCs in blood samples
Description
The number of CTCs in pre- and post-treatment blood samples will be determined.
Time Frame
Up to 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Singer, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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Hydroxychloroquine in Blocking Autophagy in Patients With Prostate Cancer Undergoing Surgery or Active Surveillance

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