Phase 1 Prostate Cancer Trial, Recruiting NCT06130995 Sponsor: University of Oklahoma Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT06130995
Recruiting 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 are able to give their signed agreement to participate in the trial.
  • People who are 18 years of age or older at the time of signing the consent form.
  • Men who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer) confirmed by a tissue test, where the cancer is either high-risk locally advanced (based on PSA level above 20, a high aggressiveness score, or tumour size) or locally advanced with any PSA or aggressiveness score but with a larger or more spread tumour in the local area.
  • People whose blood and organ function test results at screening fall within acceptable ranges, including healthy enough levels of platelets, haemoglobin, white blood cells, neutrophils, liver enzymes, bilirubin, and kidney function.
  • People with a general health and activity level rated 0, 1, or 2 on a standard oncology scale (meaning able to carry out at least some daily activities, with or without some limitations).
  • People whom the treating doctor considers to have a life expectancy of at least 6 months.
  • Men who are willing to use contraception during treatment and for 3 months after the last dose when having sex with a pregnant woman or a woman who could become pregnant. Female partners of male participants who could become pregnant should also use a highly effective form of contraception.

Who may not be able to join:

  • People who have had a major heart event — such as a heart attack, new or worsening heart failure, or a stroke — within the past 6 months.
  • People who are currently participating in another clinical trial involving an experimental treatment.
  • People whose cancer has spread to distant parts of the body (distant metastases).
  • People who have another active cancer that currently requires treatment.
  • People who have had a serious allergic reaction to a medication that is chemically or biologically similar to any of the study drugs.
  • People who have another illness that is not well controlled.
  • People who are unable to swallow pills.
  • People who are not suitable candidates for surgery or radiation therapy.

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 23 July 2026
Phase 1: approximately ~10% 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

Phone: 405-271-8777

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 1
Sponsor
University of Oklahoma
Registry
ClinicalTrials.gov
Start date
26 December 2024
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination; Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide

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: 23 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