HCQ in Resectable Localized Prostate Cancer
- Conditions
- Resectable Localized Prostate Cancer
- Registration Number
- NCT06408298
- Lead Sponsor
- Lionel.D.Lewis, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - All patients must have pathological confirmation of adenocarcinoma of the prostate<br> Gleason score 6 (grade Group 1) or greater.<br><br> - Patients must have resectable prostate cancer as defined by the AJCC (American Joint<br> Committee on Cancer) TNM system and have planned radical prostatectomy.<br><br> - Patients must have sufficient tissue from the initial diagnostic prostate biopsy, as<br> determined by the study pathologist, to perform the required study analyses without<br> exhausting the tissue required for clinical purposes<br><br> - Age >18 years<br><br> - Adequate hematopoietic, hepatic and renal function documented prior to study entry<br> to include: Hb. > 10g/dL, WBC > 3500/mm3, ANC > 1500/mm3 and platelets ><br> 100,000/mm3; hepatic transaminases (AST or ALT) = 2.0 times the upper limits of<br> normal, total bilirubin = 1.5 times the upper limits of normal, estimated creatinine<br> clearance = 60 mL/min or eGFR > 60 mL/min/1.73 m2 and normal serum cations<br> (K+/Mg2+/Ca2+)<br><br> - All patients must be medically fit candidates for radical prostatectomy.<br><br> - A patient with any retinopathy will only be enrolled into the study with the<br> approval of a board-certified ophthalmologist<br><br> - All patients must give informed consent indicating they are aware of the<br> investigational nature of this study treatment prior to any study procedures being<br> performed.<br><br>Exclusion Criteria:<br><br> - Patients may not have received radiation therapy for their prostate cancer.<br><br> - Patients may not have received chemotherapy for their prostate cancer.<br><br> - Patients with gastrointestinal abnormalities including: inability to take oral<br> medication, requirement for intravenous alimentation, or prior major surgery or<br> diseases which may cause malabsorption (e.g. bowel resection, ischemic bowel, Crohns<br> or Ulcerative colitis)<br><br> - A serious uncontrolled medical disorder or active infection which would impair their<br> ability to receive study treatment will be excluded.<br><br> - Patients with significant cardiac disease: including uncontrolled high blood<br> pressure, unstable angina, congestive heart failure, myocardial infarction within<br> the previous 3 months, or serious cardiac arrhythmias, including a QT interval<br> corrected for heart rate using the Fridericia formula of = 450 ms, or history of<br> Torsade de pointes will be excluded.<br><br> - Dementia or significantly altered mental status that would prohibit the<br> understanding or rendering of informed consent and compliance with the requirements<br> of this protocol will be excluded.<br><br> - Patients receiving any disease-modifying anti-rheumatic drugs (DMARDs) will be<br> excluded.<br><br> - Patients with known or a history of G6PD deficiency will be excluded. Eligible<br> patients will be based on clinician-investigator assessment, that the patient is not<br> at an increased risk for G6PD deficiency (assessment should include information<br> regarding self-reported race/ancestry), OR the patient has a negative screening test<br> for G6PD deficiency.<br><br> - Patients taking other commercially available medications which may theoretically<br> either stimulate or inhibit autophagy (calcitriol and chloroquine) will be excluded.<br><br> - Patients chronically taking drugs known to cause torsades de pointes will be<br> excluded unless those agents can be discontinued for a period > 6 times their<br> half-life before study enrollment<br><br> - Patients with poorly controlled diabetes mellitus will be excluded.<br><br> - Patients with a history of epilepsy will be excluded.<br><br> - Patients with a history of porphyria will be excluded
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in expression of markers of autophagy
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v5.0;Evaluate the concentration of hydroxychloroquine;Measure the tumor mutational burden;Correlation between tumor mutations and HCQ responses