Phase 2 Prostate Cancer Trial, Recruiting NCT03753243 Sponsor: Mark Garzotto, MD Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT03753243
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 who are willing and able to sign a written consent form for the trial
  • People who are able to understand and follow the trial's rules and procedures
  • People who are 18 years of age or older at the time of signing the consent form
  • People whose cancer can be measured using standard imaging criteria (known as RECIST 1.1)
  • People who have been confirmed by laboratory testing to have prostate cancer (adenocarcinoma) that has not spread to other parts of the body
  • People for whom surgical removal of the prostate (prostatectomy) with extended removal of nearby lymph nodes is planned as the main treatment
  • People expected to live 10 years or longer, based on their overall health
  • People who are generally healthy or have only mild limitations in daily activity, as rated on a standard medical scale (ECOG score of 0 or 1)
  • People who have at least one of the following high-risk cancer features: a Gleason grade of 8–10 (a measure of how aggressive the cancer appears), a PSA level above 20 ng/ml (a blood marker for prostate cancer), or a tumour stage of T3a that is considered removable by surgery
  • People with no signs that the cancer has spread (no metastases)
  • People with no other current cancer diagnosis, with the exception of certain non-serious skin cancers, or a cancer that was diagnosed and treated 5 or more years ago
  • People whose blood tests show that their organs (such as liver and kidneys) are functioning well enough, with tests completed within 30 days before starting treatment
  • Male participants who could potentially father a child must agree to use an adequate form of contraception from the first dose of the study treatment through to the time of surgery (abstinence is also acceptable if that is their usual practice)

Who may not be able to join:

  • People whose cancer has spread to other parts of the body (metastatic disease)
  • People who currently have another active cancer diagnosis (other than certain non-serious skin cancers, or a cancer diagnosed 5 or more years ago)
  • People whose organ function does not meet the required levels based on blood tests
  • People who are not willing or able to provide written consent
  • People whose overall health or activity level is too limited (ECOG score of 2 or higher)
  • People with a life expectancy of less than 10 years based on other health conditions
  • People whose prostate cancer does not include at least one of the defined high-risk features listed above

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: Mark Garzotto, MD, Portland VA Medical Center

Phone: 5032208262

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
Mark Garzotto, MD
Registry
ClinicalTrials.gov
Start date
3 December 2018
Est. completion
3 September 2022

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pathologic Complete Response

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