Phase 2 Prostate Cancer Trial, Recruiting NCT05038332 Sponsor: University of Michigan Rogel Cancer Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05038332
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 through a tissue sample) and have already had their prostate surgically removed, with a PSA blood test result of 0.1 ng/mL or higher
  • At least 6 months must have passed between the prostate removal surgery and the planned start date for radiation treatment
  • A general health and functioning score (called KPS) of 70 or above, meaning the person is reasonably able to carry out normal daily activities (confirm with trial site)
  • People who have uncertain or borderline findings on pelvic lymph nodes in scans may still be eligible, as long as the lymph nodes are no larger than 1.5 cm in their shorter measurement; if there are uncertain signs of cancer spread outside the pelvis, a biopsy confirming it is not cancer would be required
  • Ability to complete a prostate-related quality of life questionnaire called the EPIC-26
  • Tissue from the prostate removal surgery must be available for review by the Michigan Medicine Pathology department
  • Ability to understand and willingness to sign a written consent form to participate

Who may not be able to join:

  • People who have previously received radiation therapy to the pelvic area
  • People with a history of moderate to severe, or currently active, Crohn's disease or ulcerative colitis (inflammatory bowel conditions)
  • People who have had a narrowing or blockage of the bladder neck or urethra (the tube that carries urine out of the body)
  • People who have evidence that cancer has spread to distant parts of the body, or to lymph nodes beyond a certain point in the pelvis
  • People who started certain hormone-reducing therapies (known as LHRH or GnRH agonists or antagonists) more than 6 months before enrolling, or who have received other types of hormone or anti-androgen treatments for their prostate cancer
  • People who have had another serious (invasive) cancer within the past 3 years, except for certain treated skin cancers (squamous cell or basal cell carcinoma)
  • People with any other health condition that the trial doctor considers would make participation unsafe or unsuitable

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 22 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: William Jackson, M.D., University of Michigan Rogel Cancer Center

Phone: 1-800-865-1125

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
University of Michigan Rogel Cancer Center
Registry
ClinicalTrials.gov
Start date
12 November 2021
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline

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: 22 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