Prostate Cancer Trial, Recruiting NCT05423860 Sponsor: HALO Diagnostics Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT05423860
Recruiting Not Applicable

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:

  • Men who are 45 years of age or older.
  • People who have been diagnosed with a specific type of prostate cancer called prostate adenocarcinoma.
  • People whose cancer has been classified at an early stage (T1c or T2a).
  • People whose cancer has a Gleason score (a measure of how the cancer cells look under a microscope) of 7 or lower.
  • People where three or fewer biopsy tissue samples contained cancer.
  • People with a PSA density reading of no more than 0.375 (a measurement combining PSA blood test results with prostate size).
  • People where one, two, or three areas suspicious for cancer were found on a specialised MRI scan.
  • People whose MRI scan showed no signs of cancer spreading outside the prostate.
  • People with a general health and activity score (Karnofsky scale) of at least 70 out of 100.
  • People whose treating doctor has estimated a life expectancy of five years or more.
  • People who are able to tolerate anaesthesia or sedation.
  • People who are able to give informed consent to participate.
  • People who have had at least six weeks pass since their last prostate biopsy.
  • People whose MRI-guided biopsy confirmed one or more visible prostate lesions with a Gleason score of 7 or lower.
  • People who have previously had prostate cancer treatment may also be considered if referred by their doctor.

Who may not be able to join:

  • People who have a condition that makes MRI scanning unsafe, such as certain metal implants or shrapnel in the body.
  • People with severe urinary symptoms, measured by a standard symptom questionnaire score of 20 or higher.
  • People who have had another type of cancer (other than skin cancer) within the past three years.
  • People who have diabetes.
  • People who currently smoke.

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 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Christopher R. Hancock, MD, HALO Diagnostics

Phone: 760-776-8989

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
Not Applicable
Sponsor
HALO Diagnostics
Registry
ClinicalTrials.gov
Start date
16 March 2022
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Prostate cancer Gleason score; Prostate cancer ISUP grade group; Prostate cancer staging parameters; Prostate cancer specific mortality

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: 22 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