Printed from Voxsanity (voxsanity.com.au) — NCT06305598 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Bipolar Disorder Trial, Recruiting
NCT06305598
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:
- Adults aged 18 or older
- People whose general health and ability to carry out daily activities meets a certain minimum level (known as an ECOG performance status of 2 or below — confirm with trial site if unsure what this means for a specific situation)
- People who have been diagnosed with prostate cancer confirmed through a tissue sample (biopsy)
- People whose prostate cancer is continuing to grow despite ongoing treatment to lower testosterone levels (either through surgery or hormone injections)
- People whose blood testosterone level has been confirmed to be at a very low "castrate" level (below 50 ng/dL)
- People whose cancer has continued to grow after treatment with at least one type of medication that blocks androgen (male hormone) signalling — shown either through rising PSA levels or scans
- People who have tumour tissue available for testing, either from a new biopsy or from previously stored tissue samples
- People whose blood test results for white blood cells, platelets, liver function, and kidney function all fall within the required ranges (the trial site will check these)
- People whose cancer can be measured on a scan according to standard criteria (RECIST 1.1)
- People who are capable of having children and agree to use adequate contraception during the study, and who agree to inform their treating doctor immediately if pregnancy occurs or is suspected
- People who understand the experimental nature of the study and sign a written consent form approved by an ethics committee before any study procedures begin
Who may not be able to join:
- People who have received chemotherapy or radiotherapy within the 4 weeks before joining (or 6 weeks for certain specific chemotherapy drugs), or who have not yet recovered from side effects of earlier cancer treatments
- People who have cancer that has spread to the brain
- People who have cancer that has spread to more than 5 sites in the lungs or liver (small, non-specific lung nodules of 1 cm or less may still be acceptable — confirm with trial site)
- People whose cancer is located in areas where the treating doctor believes testosterone therapy could cause dangerous complications, such as a risk of bone fracture, spinal cord compression, or urinary blockage
- People with an active, uncontrolled infection, or a known history of AIDS, hepatitis B, or hepatitis C
- People whose personal, psychological, family, social, or geographical circumstances could make it difficult to follow the study schedule and requirements
- People who have had a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past 12 months and who are not currently taking blood-thinning medication
- People with a red blood cell level (haematocrit) above 50%, untreated severe sleep apnoea, or poorly controlled heart failure
- People with serious unstable medical or psychiatric conditions that could affect their safety or their ability to give informed consent
- People with a known allergy to testosterone cypionate or any of its ingredients
- People who are unwilling or unable to follow the requirements of the study
- People whom the trial doctor considers unsuitable to receive the study treatment for any reason
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.
Phase 1: approximately ~10% 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: Saby George, MD, Roswell Park Cancer Institute
Phone: 1-800-845-2300
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 1
Sponsor
Roswell Park Cancer Institute
Registry
ClinicalTrials.gov
Start date
19 December 2024
Est. completion
15 December 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Androgen receptor (AR) activity
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.