Phase 2 Prostate Cancer Trial, Recruiting NCT07313241 Sponsor: University of Texas Southwestern Medical Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT07313241
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:

  • Men aged 18 or older who have been diagnosed with prostate cancer (confirmed by tissue biopsy) and had their prostate surgically removed to treat localised cancer within the past 10 years, and whose PSA level after surgery is 0.05 ng/mL or higher (either remaining elevated or rising)
  • People whose prostate removal surgery took place at least 4 months before enrolling, and where the cancer had not spread to nearby lymph nodes at the time of surgery
  • People with a general health and activity level rated as reasonably functional (confirm with trial site for exact rating)
  • People who have had recent imaging (within the past 90 days) showing no clear signs that the cancer has spread to other parts of the body — the type of scan required depends on the PSA level at the time of registration (confirm specific imaging requirements with trial site)
  • Sexually active participants must agree to use adequate contraception throughout the study treatment period and for 60 days after it ends, and must inform their treating doctor immediately if a female partner becomes pregnant or suspects pregnancy during the study
  • People who are able to understand and willing to sign a written consent form agreeing to take part

Who may not be able to join:

  • People who have previously received hormone-blocking therapy (ADT) for more than 3 months, or anti-androgen medication for more than 30 days — shorter courses may be acceptable, but a minimum 30-day clearance period is required, along with confirmation that testosterone levels have returned above a certain threshold (confirm details with trial site)
  • People currently using testosterone replacement therapy who are unwilling to stop it — stopping is required, and specific PSA and testosterone level checks must be met after at least 14 days off the therapy
  • People who have previously had radiotherapy to the pelvic area
  • People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heart rhythm, or significant mental health or personal circumstances that the trial doctors believe would make it difficult to follow the study requirements
  • People with a history of bladder neck or urethral narrowing that has required a medical procedure to treat
  • People who have or have had another cancer whose history or treatment could interfere with the safety or results of this study, in the opinion of the trial doctors
  • People with active inflammatory bowel disease that regularly requires systemic medication or steroid-based treatments

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 8 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: Aurelie Garant, MD, University of Texas Southwestern Medical Center

Phone: 214-645-8525

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
14 November 2025
Est. completion
14 November 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Freedom from failure

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: 8 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