Phase 2 Prostate Cancer Trial, Recruiting NCT07025369 Sponsor: Mayo Clinic Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT07025369
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 aged 18 or older.
  • People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed by a tissue sample test.
  • People whose prostate cancer has been classified as high risk or very high risk based on standard medical guidelines — this includes certain tumour grades, a PSA level above 20, or specific findings on an MRI scan.
  • People with a testosterone level of 300 or above.
  • People who are reasonably active and able to care for themselves, based on a standard medical fitness scale (confirm with trial site).
  • People with blood test results within acceptable ranges — including red blood cell levels, infection-fighting white blood cells, and clotting cells — taken within the past 120 days.
  • People who agree to use a condom during sex while on the study medication and for 30 days after the last dose.
  • People who agree not to donate semen during treatment and for 30 days after the last dose.
  • People with female partners who could become pregnant, where either a vasectomy is documented, or a commitment to abstinence or effective contraception is made, for the duration of treatment and 30 days after the last dose.
  • People who are willing and able to provide written consent to participate.

Who may not be able to join:

  • People who have received chemotherapy within the past 2 weeks before joining the trial.
  • People who have previously received hormone therapy to reduce androgen (male hormone) levels.
  • People who have previously received radiation treatment to the pelvic area.
  • People with serious ongoing health conditions that, in the treating doctor's judgement, would make participation unsafe or affect the accuracy of results.
  • People with uncontrolled health problems such as an active infection, heart failure with symptoms, unstable chest pain, irregular heart rhythm, or mental health or personal circumstances that could make it difficult to follow the study requirements.
  • People currently taking part in another clinical trial that involves a treatment for their prostate cancer.
  • People who have had another active cancer within the past year — with the exception of certain non-melanoma skin cancers — or who are currently receiving treatment for a prior cancer.
  • People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for serious heart rhythm problems.
  • People currently taking a type of medication known as a P-glycoprotein inhibitor (confirm with trial site for specific medicines that fall into this category).

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 14 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: Jack R. Andrews, MD, Mayo Clinic

Phone: 855-776-0015

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
Sponsor
Registry
ClinicalTrials.gov
Start date
25 August 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum standard uptake value (SUVmax) for pre and post androgen deprivation therapy (ADT) prostate-specific antigen (PSMA) positron emission tomography (PET); Mean standard uptake value (SUVmean) for pre and post ADT PSMA PET

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: 14 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