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New treatment option for Resectable Localized Prostate Cancer
Official title HCQ in Resectable Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06408298
What this study is testing
What is Hydroxychloroquine Sulfate 400Mg Tab?
Hydroxychloroquine Sulfate 400Mg Tab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for resectable localized prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Patients must have sufficient tissue from the initial diagnostic prostate biopsy, as determined by the study pathologist, to perform the required...
- 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...
You likely can't join if
- 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...
- 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...
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the...
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.