Phase 2 Prostate Cancer Trial, Recruiting NCT04337580 Sponsor: Wake Forest University Health Sciences Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT04337580
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 prostate cancer that has continued to grow despite hormone therapy (called castrate refractory prostate cancer) and who have previously been treated with a chemotherapy drug called docetaxel for this stage of the disease
  • People whose cancer has been confirmed to be progressing, which may show up as rising PSA levels, new or worsening bone involvement, lymph node changes, or new areas of cancer growth
  • People aged 18 or older
  • People who are reasonably physically functional — rated 0, 1, or 2 on a standard activity scale used by doctors (confirm with trial site)
  • People whose life expectancy is estimated to be more than 2 months
  • Men who agree to use adequate contraception (such as barrier methods or abstinence) from the time of joining the trial until 3 months after treatment ends
  • People who are able to understand and willing to sign a consent form approved by an ethics board (or who have a legal representative who can do so on their behalf)
  • People whose blood test results show that the bone marrow, liver, and kidneys are functioning within acceptable levels as defined by the trial (confirm with trial site for specific values)

Who may not be able to join:

  • People who are currently taking part in another clinical trial involving an experimental treatment
  • People who have had a serious allergic reaction to drugs chemically similar to omeprazole (a common stomach acid medication) or to taxane-type chemotherapy drugs
  • People with serious ongoing health conditions that are not well controlled, such as an active infection, heart failure, unstable chest pain, an irregular heartbeat, or a mental health or personal situation that could make it difficult to follow the trial requirements

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 20 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: Michael Goodman, MD, Wake Forest University Health Sciences

Phone: 336-716-5772

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
5 March 2021
Est. completion
1 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change Radiographic Response - RECIST 1.1; Change in Bone Metastasis Response - Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

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: 20 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