Phase 2 Prostate Cancer Trial, Recruiting NCT06014255 Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06014255
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 have been diagnosed with prostate cancer (adenocarcinoma type) confirmed by a tissue sample, where the cancer is at an early-to-locally advanced stage and has not spread to the lymph nodes, bones, or other organs — though a small number of lymph node findings on a specific type of scan (PSMA scan) may be allowed (confirm with trial site)
  • People whose initial prostate biopsy was done within the last 3 months, is available for review by the trial's pathology team, and shows a high-grade cancer pattern meeting specific scoring thresholds (confirm with trial site for exact biopsy requirements)
  • People who have already had surgery to remove the prostate (radical prostatectomy) scheduled
  • People aged 18 or older
  • People who are generally in good physical health and able to carry out daily activities, as measured by standard health performance scales (confirm with trial site)
  • People whose blood, liver, and kidney function test results fall within acceptable ranges as defined by the trial (confirm with trial site for specific values)
  • People willing to sign a consent form and allow their health information to be shared as required by the study
  • People willing to use barrier contraception (such as condoms) from the first dose of the study drug until the time of their prostate surgery

Who may not be able to join:

  • People whose cancer has spread to the lymph nodes (as seen on a CT scan) beyond what the trial allows, or to distant parts of the body
  • People whose prostate cancer is a less common type, such as ductal, sarcomatous, lymphoma, small cell, or neuroendocrine prostate cancer
  • People who have previously received radiation therapy, hormone therapy, biological therapy, or chemotherapy for prostate cancer
  • People who have previously received immunotherapy or vaccine-based therapy for prostate cancer
  • People who have previously used experimental treatments for prostate cancer
  • People currently taking other hormone therapies or a type of medication called 5-alpha-reductase inhibitors at the same time as the study treatment
  • People currently using steroid medications taken throughout the whole body (systemic corticosteroids), or who have used them within the past 4 weeks — though inhaled steroids for asthma or lung conditions, and creams or other non-systemic steroids, are generally permitted
  • People with a history of, or currently having, an autoimmune disease that requires medication to suppress the immune system (such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions)
  • People who have had another cancer diagnosed within the last 3 years, with the exception of certain skin cancers and superficial bladder cancer
  • People with serious uncontrolled health conditions affecting the heart, lungs, blood, mental health, or involving active infection, which could make participation unsafe
  • People with a known history of HIV, or current or past hepatitis B or C — except for people who have been fully and successfully treated for hepatitis B or C, with documented proof of cure at least 6 months after completing that treatment

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: Eugene Shenderov, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phone: 4109551239

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
16 February 2024
Est. completion
1 March 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Recurrence-free survival (RFS)

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