RecruitingEarly Phase 1

HCQ in Resectable Localized Prostate Cancer

A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests hydroxychloroquine (HCQ), a medicine taken by mouth, against a placebo (a pill with no active medicine). It is for adults with prostate cancer that has stayed in the prostate and can be removed with surgery. Researchers will study how HCQ affects cell recycling in the cancer and check its safety before and around surgery.

This is randomized, double blind, placebo controlled proof of principle (window of opportunity) study of oral hydroxychloroquine in patients with resectable localized prostate cancer. To determine the effects of hydroxychloroquine (HCQ) on markers of autophagy, such as p62, LC3-II and NBR-1 in prostate cancer tissue of patients with resectable localized prostate cancer who undergo radical prostatectomy. To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy. To evaluate the concentration of hydroxychloroquine in normal and prostate tumor tissue and to correlate prostate tissue concentrations with the plasma concentrations in these patients. To perform tumor genomic analysis (for common somatic mutations) and to correlate the molecular response to HCQ and presence/absence of such mutations.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18.
  • A tissue test must confirm prostate adenocarcinoma, a type of prostate cancer, with a Gleason score of 6 or higher.
  • Your cancer must be removable by surgery, and you must plan to have surgery to remove the prostate.
  • You must be healthy enough for prostate removal surgery.
  • Enough tissue from your first prostate biopsy must be available for study tests and your regular care.
  • Blood tests must meet the study’s limits for blood cell counts, liver and kidney health, and mineral levels.
  • If you have retinopathy (damage to the back of the eye), a board-certified eye doctor must approve your enrollment.
  • You must give informed consent before any study procedures, showing you understand the treatment is being studied.

Who can't join

  • You have had radiation or chemotherapy for prostate cancer.
  • You cannot take medicine by mouth, need nutrition through a vein, or have bowel disease or past surgery that may keep your body from absorbing medicine.
  • You have a serious uncontrolled illness, an active infection that would make treatment unsafe, or poorly controlled diabetes.
  • You have serious heart disease, such as uncontrolled high blood pressure, unstable chest pain, heart failure, a heart attack in the past 3 months, or certain abnormal heart rhythms.
  • You have dementia or major changes in thinking that prevent you from understanding consent or following study rules.
  • You take disease-modifying drugs for arthritis, calcitriol, or chloroquine. Regular use of drugs that can cause a dangerous heart rhythm called torsades de pointes also excludes you unless they can be stopped long enough before enrollment.
  • You have or have had G6PD deficiency, a condition that can damage red blood cells. A study doctor must find that you are not at increased risk, or a screening test must be negative.
  • You have a history of epilepsy (a seizure disorder) or porphyria (a disorder that affects how the body makes part of blood).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * All patients must have pathological confirmation of adenocarcinoma of the prostate Gleason score 6 (grade Group 1) or greater. * Patients must have resectable prostate cancer as defined by the AJCC (American Joint Committee on Cancer) TNM system and have planned radical prostatectomy. * Patients must have sufficient tissue from the initial diagnostic prostate biopsy, as determined by the study pathologist, to perform the required study analyses without exhausting the tissue required for clinical purposes * Age \>18 years * Adequate hematopoietic, hepatic and renal function documented prior to study entry to include: Hb. \> 10g/dL, WBC \> 3500/mm3, ANC \> 1500/mm3 and platelets \> 100,000/mm3; hepatic transaminases (AST or ALT) ≤ 2.0 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, estimated creatinine clearance ≥ 60 mL/min or eGFR \> 60 mL/min/1.73 m2 and normal serum cations (K+/Mg2+/Ca2+) * All patients must be medically fit candidates for radical prostatectomy. * A patient with any retinopathy will only be enrolled into the study with the approval of a board-certified ophthalmologist * All patients must give informed consent indicating they are aware of the investigational nature of this study treatment prior to any study procedures being performed. Exclusion Criteria: * Patients may not have received radiation therapy for their prostate cancer. * Patients may not have received chemotherapy for their prostate cancer. * Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior major surgery or diseases which may cause malabsorption (e.g. bowel resection, ischemic bowel, Crohns or Ulcerative colitis) * A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. * Patients with significant cardiac disease: including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 3 months, or serious cardiac arrhythmias, including a QT interval corrected for heart rate using the Fridericia formula of ≥ 450 ms, or history of Torsade de pointes will be excluded. * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded. * Patients receiving any disease-modifying anti-rheumatic drugs (DMARDs) will be excluded. * Patients with known or a history of G6PD deficiency will be excluded. Eligible patients will be based on clinician-investigator assessment, that the patient is not at an increased risk for G6PD deficiency (assessment should include information regarding self-reported race/ancestry), OR the patient has a negative screening test for G6PD deficiency. * Patients taking other commercially available medications which may theoretically either stimulate or inhibit autophagy (calcitriol and chloroquine) will be excluded. * Patients chronically taking drugs known to cause torsades de pointes will be excluded unless those agents can be discontinued for a period \> 6 times their half-life before study enrollment * Patients with poorly controlled diabetes mellitus will be excluded. * Patients with a history of epilepsy will be excluded. * Patients with a history of porphyria will be excluded

Study sites (1)

NH