Early Phase 1 Prostate Cancer Trial, Recruiting NCT06408298 Sponsor: Lionel.D.Lewis, MD Condition: Prostate Cancer
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Early Phase 1 Prostate Cancer Trial, Recruiting

NCT06408298
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with prostate cancer confirmed by a pathologist, with a Gleason score of 6 or higher (a measure of how the cancer cells look under a microscope).
  • People whose prostate cancer is considered removable by surgery, and who already have a planned surgery to remove the prostate (called a radical prostatectomy).
  • People who have enough tissue remaining from their original prostate biopsy for the study's laboratory tests, without using up what is needed for regular medical care.
  • People aged over 18 years.
  • People whose blood counts, liver function, and kidney function meet specific minimum levels before entering the study (including healthy red and white blood cell counts, platelet levels, liver enzyme levels, and kidney filtration rates within required ranges).
  • People who are considered medically well enough to undergo surgery to remove the prostate.
  • People with any eye condition affecting the retina may only be considered for the trial if an eye specialist (ophthalmologist) gives their approval.
  • People who have been fully informed about the investigational nature of the study and have given written consent before any study procedures begin.

Who may not be able to join:

  • People who have previously received radiation therapy for their prostate cancer.
  • People who have previously received chemotherapy for their prostate cancer.
  • People who have digestive or bowel problems that prevent them from swallowing medication, require feeding through a vein, or who have had major bowel surgery or conditions that affect how the body absorbs food (such as Crohn's disease, ulcerative colitis, or bowel removal surgery).
  • People who have a serious uncontrolled medical condition or an active infection that could interfere with receiving the study treatment.
  • People with significant heart problems, including uncontrolled high blood pressure, unstable chest pain (angina), heart failure, a heart attack in the past 3 months, serious irregular heart rhythms, a specific heart electrical measurement (corrected QT interval) of 450 ms or more, or a history of a dangerous heart rhythm called Torsade de pointes.
  • People with dementia or a significantly reduced mental capacity that would prevent them from understanding the study or giving informed consent.
  • People currently taking medications known as disease-modifying anti-rheumatic drugs (DMARDs), which are used to treat conditions like rheumatoid arthritis.
  • People with a known or past diagnosis of a genetic condition called G6PD deficiency, or people assessed by the treating doctor as being at increased risk for this condition, unless a screening test has come back negative (confirm with trial site).
  • People currently taking certain commercially available medications — specifically calcitriol or chloroquine — that may affect a cell process called autophagy.
  • People regularly taking medications known to cause a specific dangerous heart rhythm (Torsade de pointes), unless those medications can be stopped for long enough before joining the study (confirm with trial site).
  • People with poorly controlled diabetes.
  • People with a history of epilepsy.
  • People with a history of a condition called porphyria (a rare disorder affecting the body's production of a substance called porphyrin).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Lionel Lewis, MB BCh., MD, Dartmouth-Hitchcock Medical Center

Phone: 16036506227

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Lionel.D.Lewis, MD
Registry
ClinicalTrials.gov
Start date
6 January 2026
Est. completion
1 February 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in expression of markers of autophagy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov