Phase 2 Prostate Cancer Trial, Recruiting NCT05036226 Sponsor: Medical University of South Carolina Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05036226
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 advanced solid tumour cancer of any type (Phase I of the trial) or advanced prostate cancer with a PSA level of at least 0.1 ng/mL (Phase II of the trial)
  • People whose cancer diagnosis has been confirmed by a pathology report or documented clinical note
  • People whose cancer can be measured or tracked through scans, blood tests, or specialised imaging
  • People who have given voluntary, signed, and dated consent on a form approved by the relevant review board
  • People whose cancer has continued to grow or spread despite receiving one or more standard treatments, such as chemotherapy, hormone therapy, radiation, surgery, immunotherapy, or cell therapy
  • People aged 18 years or older
  • People with a general health and activity level rated 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities independently (confirm with trial site)
  • People whose liver function blood test results are within the ranges required by the trial, including specific allowances for people with a condition called Gilbert's syndrome (confirm with trial site)
  • People whose kidney function blood test results are within the range required by the trial (confirm with trial site)
  • People whose blood cell counts — including white blood cells, platelets, and haemoglobin — meet the minimum levels required by the trial (confirm with trial site)
  • People whose blood sugar levels fall within the acceptable range for this trial, whether fasting or non-fasting (confirm with trial site)
  • People whose urine test results show no significant abnormalities
  • People whose blood pressure is adequately controlled, as determined by the treating doctor
  • People who are capable of having children and who agree to use effective contraception for the duration of the trial
  • People who need narcotic pain medication and have been on a stable dose for at least 2 weeks before joining the trial
  • People being considered for a treatment dose that includes a drug called nelfinavir mesylate must stop taking any statin medications at least 48 hours before starting trial treatment

Who may not be able to join:

  • People with serious heart conditions, including severe heart failure (New York Heart Association Class III or IV), a heart attack in the past 6 months, an unstable heart rhythm, or a history of reduced blood flow to the heart shown on a heart trace (ECG)
  • People who have been hospitalised for a psychiatric condition within the last two years
  • People with a significant neurological condition such as Parkinson's disease, dementia, or multiple sclerosis, as assessed by the enrolling doctor
  • People who have an active, uncontrolled infection (bacterial, viral, or fungal) that requires systemic treatment
  • People who have received radiation therapy, surgery, or another investigational treatment within 28 days before registering for the trial
  • People who are unwilling or unable to follow the procedures required by the trial
  • People with a serious non-cancer illness that the investigator believes could interfere with the trial's goals
  • People who are currently taking blood-thinning medications including coumadin (warfarin), apixaban, argatroban, or rivaroxaban
  • People who are currently taking part in another clinical trial of an investigational product
  • People with any other mental health condition that the enrolling doctor determines would prevent safe participation in the trial
  • People who are prisoners or who are involuntarily detained for treatment of a psychiatric or physical illness

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 15 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

Phone: 843-792-9321

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
3 March 2022
Est. completion
21 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD) - Phase I; Measure of proportion of patients with disease control - Phase II

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: 15 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