Phase 2 Prostate Cancer Trial, Recruiting NCT05790213 Sponsor: University of Chicago Condition: Prostate Cancer
Back to Prostate Cancer

Phase 2 Prostate Cancer Trial, Recruiting

NCT05790213
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 diagnosed with intermediate-risk prostate cancer, either "favorable" or "unfavorable" type, based on specific measurements of cancer stage, cancer grade (Grade Group 2 or 3), PSA level, and how many biopsy samples contained cancer cells.
  • People whose MRI scan shows no signs that the cancer has grown outside the prostate gland or into nearby structures called seminal vesicles (if there is any suspicion of spread to the seminal vesicles, a biopsy must confirm it has not spread).
  • People who have decided to pursue Focal Therapy as their chosen treatment for prostate cancer.
  • People with unfavorable intermediate-risk prostate cancer who have had recent scans (within 6 months) confirming the cancer has not spread to other parts of the body; this imaging is not required for those with favorable intermediate-risk prostate cancer.
  • Men aged 18 years or older.
  • People whose treating doctor estimates they have a life expectancy of at least 10 years.
  • People with a general health and activity level that falls within certain medical rating scales, indicating they are reasonably able to carry out daily activities (confirm with trial site for exact thresholds).
  • People who are physically able to undergo general anaesthesia and the focal therapy surgical procedure, including being able to tolerate a specific surgical position and having suitable anatomy for the procedure, in the opinion of the treating doctor.
  • People whose blood and organ function test results meet specific minimum levels for red blood cells, white blood cells, platelets, liver function, kidney function, and certain other blood markers (confirm with trial site for exact values).
  • People who have or have had another type of cancer, as long as that cancer or its treatment is unlikely to interfere with this trial's safety or results.
  • People who are sexually active with a partner who could become pregnant must agree to use a condom with spermicide, and their partner must also use a highly effective form of contraception, during treatment and for 3 months after the last hormone therapy dose.
  • People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

  • People who have previously had or are currently receiving any treatment for prostate cancer, including hormone therapy, chemotherapy, radiation, surgery, or biological therapies; also excluded are people who received radiation, chemotherapy, or immunotherapy for any other cancer within 6 months of enrolling.
  • People whose prostate cancer has already spread locally beyond the prostate, to lymph nodes, or to other parts of the body.
  • People who are unable to undergo a pelvic MRI scan — for example, due to severe claustrophobia, a permanent cardiac pacemaker, certain metal implants that would affect image quality, or an allergy or medical reason preventing use of the contrast dye used in MRI.
  • People with a known allergy or intolerance to any components of the study drug.
  • People who have had both testicles surgically removed.
  • People with a serious illness that is not well controlled.
  • People who are currently taking part in another clinical trial involving an investigational treatment; those who have previously taken part in such a trial may still be considered, at the discretion of the principal investigator.
  • People who the treating doctor or principal investigator considers unsuitable for the study, or who are unlikely to follow the study's procedures and 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 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: Abhinav Sidana, MD, University of Chicago

Phone: 1-855-702-8222

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 May 2025
Est. completion
18 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with clinically significant residual prostate cancer in ablated prostate tissue following study treatment; Number of participants with clinically significant residual prostate cancer in unablated prostate tissue following study treatment; Number and grade of complications [Safety]

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