Phase 2 Prostate Cancer Trial, Recruiting NCT06150417 Sponsor: Case Comprehensive Cancer Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06150417
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 18 years of age or older.
  • People whose overall health and ability to carry out daily activities meets a certain fitness level (confirm with trial site).
  • People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) that has spread to other parts of the body, confirmed by imaging scans such as MRI, CT, bone scan, or a specialised PET/CT scan.
  • Tissue samples from the original tumour must be available — specifically at least 10–15 unstained slides from 2 tissue samples with a high amount of tumour cells.
  • People who have been newly diagnosed and have not yet received surgery, radiation, or systemic treatments (such as hormone therapy or chemotherapy) for their prostate cancer — though hormone-related medications started no more than 30 days before joining the trial may be acceptable.
  • People whose cancer has spread to a limited number of sites (called oligometastatic disease): if standard imaging was used, this means 1–5 sites in the bones or lymph nodes outside the pelvis; if the specialised PSMA PET/CT scan was used, this means 1–10 affected bone or lymph node sites outside the pelvis.
  • For people whose PSMA PET/CT scan shows lymph node spread outside the pelvis but standard imaging does not confirm this, at least 2 of the following 3 criteria must be met: a PSA level of 40 or higher; evidence of pelvic lymph node involvement; or a specific tumour gene score of 0.89 or higher (confirm with trial site).
  • People whose organs (such as kidneys, liver, and bone marrow) are functioning well enough to receive treatment, as determined by the treating doctor.
  • People who are well enough to receive treatment and are willing to attend follow-up appointments.
  • People who are able to understand and are willing to sign a consent form.

Who may not be able to join:

  • People whose prostate cancer has become resistant to hormone (castration) therapy.
  • People whose cancer has spread to internal organs or the brain.
  • People who are currently taking part in another clinical trial involving a cancer treatment.
  • People who are currently receiving another experimental cancer treatment.
  • People who are unable to lie flat or cannot tolerate the required PET/MRI, PET/CT, or radiation treatment sessions.
  • People who have already received definitive treatment (such as surgery or radiation) to the prostate or pelvis.
  • People with serious uncontrolled health conditions, such as active infection, heart failure, unstable chest pain, irregular heart rhythm, poorly controlled diabetes, active hormonal gland disorders, or mental health or social circumstances that would make it difficult to follow the trial requirements.
  • People who have had another active cancer in the past 2 years, with the exception of certain low-risk skin cancers, early-stage bladder cancer, or a cancer considered to be fully cured with very low chance of returning.
  • People with active Crohn's disease or ulcerative colitis that is not well controlled despite medical treatment.
  • People who are unwilling to sign the consent form.
  • People who have any other condition that, in the opinion of the trial doctor, would make participation 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 21 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: Angela Y Jia, MD, PhD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Phone: 216-844-3262

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
1 July 2024
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Failure-free survival (FFS)

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: 21 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