Phase 2 Prostate Cancer Trial, Recruiting NCT04038502 Sponsor: VA Office of Research and Development Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04038502
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 have signed the required consent and privacy authorization forms
  • Men over 18 years of age
  • People with a diagnosis of prostate cancer (certain rare types — pure small-cell or pure high-grade neuroendocrine — are not eligible, but prostate cancer that shows some neuroendocrine features is allowed)
  • People who are receiving hormone therapy to lower testosterone (either through medication that blocks hormone signals, or through surgical removal of the testicles), and whose testosterone blood level is below 50 ng/ml
  • People whose prostate cancer has spread to other parts of the body and is no longer responding to hormone therapy, shown by rising PSA levels, visible disease growth on scans, or new bone lesions appearing on imaging
  • People who have previously been treated with at least one of these medications: abiraterone acetate, enzalutamide, apalutamide, or darolutamide
  • People who are generally well enough to carry out light activity and care for themselves (a specific fitness scale score of less than 2 is required — confirm with trial site)
  • People whose DNA test results — from tumour tissue, a blood sample, or an earlier research test — show a specific genetic mutation in one of these genes: RAD51B, RAD51C, RAD51D, or RAD54L, confirmed by an accredited laboratory
  • People with healthy enough blood counts, liver function, and kidney function within 28 days before starting the study treatment, meeting specific minimum levels set by the trial (confirm exact values with trial site)

Who may not be able to join:

  • People currently receiving active treatment for another cancer
  • People already enrolled in another clinical trial involving an investigational drug or device
  • People whose cancer biopsy shows small cell carcinoma based on how the cells look under a microscope
  • People who have previously received platinum-based chemotherapy, mitoxantrone, or a PARP inhibitor for castration-resistant prostate cancer
  • People with known cancer spread to the brain tissue itself
  • People with active or symptomatic viral hepatitis or chronic liver disease, or abnormal liver function levels above the thresholds set by the trial (unless a specific condition called Gilbert's syndrome is the cause)
  • People with a blood disorder called myelodysplastic syndrome or acute myeloid leukemia, or signs that suggest either condition
  • People currently taking certain medications that strongly or moderately affect how the body processes drugs (known as CYP3A inhibitors or inducers — examples include itraconazole, clarithromycin, rifampicin, phenytoin, and St John's Wort, among others); a waiting period off these medications may be required before joining (confirm with trial site)
  • People who are unable to swallow tablets or capsules, or who have digestive conditions that would prevent the study medication from being absorbed properly
  • People with serious heart disease, including a heart attack or blood clot in the past 6 months, severe chest pain, significant heart failure, or a weakened heart pump function below 35%
  • People who have received another experimental treatment within 30 days before the trial starts
  • People with dementia, significant psychiatric illness, or personal circumstances that would make it difficult to follow the trial requirements or to understand and sign consent forms
  • People with any other medical or personal condition that the trial doctors believe would put the person 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
1 October 2019
Est. completion
31 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free survival (PFS-1L) defined as the time interval between randomization and first documented disease progression or death due to any cause reported during, or after, first-line treatment.

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