Phase 2 Prostate Cancer Trial, Recruiting NCT05454488 Sponsor: M.D. Anderson Cancer Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05454488
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:

  • You are a male adult who speaks English
  • Your doctor believes you are expected to live for more than 10 years
  • You have had an MRI-guided biopsy of a visible area on your prostate MRI before joining the trial (including additional biopsy samples taken in a standard pattern)
  • You have been diagnosed with a specific type and stage of prostate cancer (Grade Group 2 or 3, limited to one area, and confined within the prostate — with any lower-grade cancer nearby being very small, 6mm or less)
  • Your prostate cancer has been confirmed as adenocarcinoma (a specific cancer type) through a biopsy
  • Your cancer has not spread beyond the prostate, and there is no clear sign it has grown into nearby tissues or glands on MRI
  • Your biopsy was done through a specific approach and included at least 2 targeted samples plus a standard 12-sample pattern
  • Your PSA blood test result is 15 or below, or meets a related measurement if it is higher (confirm with trial site)
  • Your doctor can fully see your prostate using ultrasound during the biopsy
  • Your doctor believes the affected area of your prostate can be treated with cryotherapy (freezing treatment)
  • You are willing and able to read and sign the consent form for this study
  • You are willing to follow all study requirements, including the freezing treatment and all follow-up appointments
  • You agree to take part in a related laboratory research study

Who may not be able to join:

  • Your prostate cancer is classified as a higher grade (Grade Group 4 or 5)
  • You have another medical condition that your doctor believes makes surgery or anesthesia too risky for you
  • You currently have a urinary tract infection
  • You have previously received any treatment for prostate cancer, including radiation, hormone therapy, biological therapy, or chemotherapy
  • You have previously had a prostate procedure such as TURP, laser treatment, microwave treatment, water-based treatment, UroLift, or surgical removal of part of the prostate (confirm with trial site for specific procedures)
  • You have had previous rectal surgery (other than a minor hemorrhoid procedure) or have a history of rectal disease
  • You are unable to have an MRI scan, for example due to claustrophobia, a pacemaker, or certain implants in your body
  • You are not willing to take part in the related laboratory research study

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 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: Justin Gregg, MD, jrgregg@mdanderson.org

Phone: 713-792-3250

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
25 July 2022
Est. completion
31 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Quality-of-life Questionnaires

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