Phase 2 Prostate Cancer Trial, Recruiting NCT05011383 Sponsor: VA Office of Research and Development Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05011383
Recruiting Phase 2

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 are willing to sign a consent form agreeing to follow the study schedule, attend all visits, and allow their health information to be used for research
  • Men aged over 18 years
  • People who have been diagnosed with prostate cancer (adenocarcinoma type) confirmed by a tissue or cell sample
  • People who are receiving hormone therapy to reduce testosterone (either through medication or surgical removal of the testicles) and are continuing that treatment
  • People whose prostate cancer has stopped responding to hormone therapy, shown by testosterone levels below 50 ng/ml and at least one of: rising PSA levels on two tests at least one week apart; measurable disease progression on scans; or more than two new spots appearing on a bone scan
  • People who have cancer that has spread to bones or other areas, confirmed by bone or CT scan
  • People whose cancer has continued to grow after being treated with at least one newer type of hormone-blocking medication (such as abiraterone, enzalutamide, apalutamide, or darolutamide)
  • People who have no symptoms, or only mild symptoms, related to their prostate cancer
  • People who are generally able to carry out daily activities with little or no limitation (confirm with trial site regarding specific fitness scoring used)
  • People whose tumour has specific gene changes (mutations in ATM, CDK12, or CHEK2) detected by an approved laboratory DNA test

Who may not be able to join:

  • People who are currently receiving active treatment for another type of cancer
  • People whose prostate cancer has a specific aggressive cell type called small cell carcinoma, identified by how the cells look under a microscope
  • People who have cancer that has spread to the brain
  • People who have cancer that has spread to the liver
  • People with active or symptomatic hepatitis, chronic liver disease, or certain abnormal liver blood test results (unless caused by a specific harmless condition called Gilbert's syndrome)
  • People who have had a heart attack, serious blood clot in an artery, severe chest pain, significant heart failure, or a low heart pumping function within the past 6 months
  • People who need opioid (strong prescription) pain medication to manage pain caused by their prostate cancer
  • People whose tumour is blocking the urinary passage and requires a catheter to urinate (though people who need a catheter for non-cancer-related reasons may still be eligible)
  • People with dementia, a psychiatric illness, or personal circumstances that would make it difficult to follow the study requirements or to understand and sign the consent form
  • People with any other medical or personal condition that the study doctors believe could put them at risk or affect the reliability of the study results

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Robert B. Montgomery, MD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Phone: (206) 277-6878

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
Phase 2
Registry
ClinicalTrials.gov
Start date
31 August 2021
Est. completion
31 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

PSA response

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: 28 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