NCT02421575

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

Assessment of the Biological Effect of Autophagic Inhibition With Hydroxychloroquine in Prostate Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-02-26
• Completion: 2016-02-26
• First posted: 2015-04-20
• Last updated: 2017-02-02

Locations

1 site across 1 country: United States