Phase 2 Prostate Cancer Trial, Recruiting NCT05869682 Sponsor: City of Hope Medical Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05869682
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 confirmed by a laboratory test of tissue or cells
  • People who have measurable signs of the disease visible on a CT scan, MRI, bone scan, or a specialised PET scan (such as Axumin or PSMA-PET)
  • People whose doctor has planned treatment with one of the following approaches: a hormone-blocking therapy (ADT) combined with docetaxel, abiraterone, and either prednisone or darolutamide (a three-drug combination); or ADT combined with enzalutamide, apalutamide, or darolutamide (a two-drug combination); previous use of ADT or surgical removal of the testicles is allowed
  • People aged 60 years or older
  • People with a general health and activity level rated at a moderate level or better (confirm with trial site for exact rating details)
  • People whose doctor estimates the time before needing a new treatment will be at least 12 months, and whose life expectancy is at least 18 months
  • People with blood counts and organ function results within acceptable ranges, including adequate white blood cell, neutrophil, and platelet counts, normal liver function, normal bilirubin levels, and adequate kidney function (confirm with trial site for specific values)
  • People living with HIV who are on effective treatment and have had an undetectable level of the virus in the past 6 months
  • People with a history of hepatitis B who have an undetectable viral load while on the appropriate treatment
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load
  • People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this trial
  • People with a history of heart disease or prior treatment with heart-affecting medications, provided a heart function assessment places them in an acceptable category (class 2B or better on a standard medical scale)
  • People who are willing and able to understand and sign a consent form agreeing to take part
  • People who switch to a different eligible hormonal treatment (but not due to cancer progression) may still be able to continue in the trial

Who may not be able to join:

  • People receiving docetaxel who have a form of advanced prostate cancer that no longer responds to hormone-blocking therapy (castration-resistant prostate cancer), because the expected time before needing the next treatment is typically less than 12 months
  • People who have not fully recovered from side effects of a previous cancer treatment (with the exception of hair loss)
  • People who have previously been treated with combination hormonal therapy using abiraterone, enzalutamide, apalutamide, or darolutamide, if they are planning to start one of those same treatments in this trial
  • People who are currently taking part in another clinical trial involving an experimental treatment
  • People whose prostate cancer has spread to the brain
  • People with a history of serious allergic reactions to medications that are chemically similar to those used in this trial
  • People whose laboratory results show a particular aggressive type of prostate cancer called small cell prostate cancer
  • People who have had serious bone-related complications from prostate cancer — such as spinal cord compression, a bone fracture, or the need for radiation or surgery on a bone — within the past 6 months
  • People with pain from prostate cancer or another ongoing condition that is not well controlled
  • People whose prostate cancer appears to be progressing very rapidly, with a life expectancy of less than 18 months
  • People with other serious illnesses that are not well controlled
  • People who currently have a second active cancer (separate from prostate cancer)
  • People with severe sleep disorders, such as narcolepsy
  • People with eye conditions that prevent light from being processed normally, such as untreated cataracts, severe glaucoma, macular degeneration, blindness, or other retinal disorders
  • People with severe psychological conditions such as bipolar disorder or manic episodes
  • People who currently work night shifts
  • People who have previously used light therapy to treat fatigue or low mood
  • People who have had eye surgery in the past 6 months and are still experiencing eye irritation as a result
  • People with sensitivity to light, epilepsy, or a history of seizures

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 13 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
9 July 2024
Est. completion
30 November 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in patient-reported fatigue

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: 13 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