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Study on the Safety and Effects of PT-112 for Patients with Advanced Prostate Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as metastatic castration-resistant prostate cancer. This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The treatment being tested in this study is a medication called PT-112, which is given as a solution through an intravenous infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effects of PT-112 in patients with advanced solid tumors, including prostate cancer. The study will explore different doses of the medication to determine the most effective and safe dose for future studies. Participants will receive the medication on specific days within a 28-day cycle, and the study will monitor how the cancer responds to the treatment over time.

Throughout the study, researchers will assess various outcomes, such as the rate at which the disease is controlled, the response of the tumors to the treatment, and any side effects experienced by the participants. The study aims to gather important information that could help in developing new treatment options for patients with advanced prostate cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will have signed an informed consent form. This indicates understanding and agreement to participate in the study.

    The patient must meet specific health criteria, such as having a good performance status and adequate organ function.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with PT-112, a solution administered through an intravenous infusion.

    The treatment involves two different dosage levels: 250 mg/m² and 360 mg/m².

  3. Step 3

    Treatment cycle

    The treatment is structured in 28-day cycles. During each cycle, the patient receives the infusion on Day 1 and Day 15.

    In the modified design, the patient may receive 360 mg/m² on Days 1 and 15 of the first cycle, then 250 mg/m² on Day 15 of each subsequent cycle.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment are closely monitored.

    Regular assessments include tumor evaluations using imaging techniques and blood tests to measure specific markers.

  5. Step 5

    Follow-up

    After completing the treatment cycles, the patient will continue to be monitored for any long-term effects and overall health status.

    Follow-up visits and assessments are scheduled to ensure the patient's well-being and to gather data on the treatment's effectiveness.

Who can join the trial?

15 criteria

  • Must sign a form agreeing to participate in the study before any study-specific procedures and treatment begin.
  • Must have an **ECOG performance status** of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
  • Must have an estimated life expectancy of at least 16 weeks.
  • Must have recovered from any significant side effects from previous cancer treatments, except for hair loss or side effects from hormone therapy, to a level considered mild or less.
  • Must have adequate function of the bone marrow, liver, and kidneys.
  • Must use a condom during the study treatment and for 6 months after the last dose when having intercourse with a pregnant woman or a woman who can become pregnant. Female partners should also use a highly effective form of birth control if they can become pregnant.
  • Must be willing and able to follow the study's rules, including attending treatment sessions, scheduled visits, and examinations, and completing required surveys and follow-up visits.
  • Must be a male aged 18 years or older.
  • Must have a confirmed diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer, excluding certain rare types at the original diagnosis.
  • Must have current evidence of **metastatic castration-resistant prostate cancer (mCRPC)**, meaning the cancer has spread to other parts of the body and is not responding to hormone therapy. This must be shown by scans, and the spread should not be limited to nearby pelvic lymph nodes or local recurrence.
  • Must be undergoing ongoing hormone therapy to lower testosterone levels, either through medication or surgery.
  • Must have a **serum testosterone level** of 1.73 nmol/L (50 ng/dL) or lower at the time of screening.
  • If receiving medications like bisphosphonates or denosumab for bone health, must have been on a stable dose for at least 4 weeks before starting the study. Bisphosphonates should not be taken within 7 days before starting the study treatment. Denosumab can be taken on the same day as the study drug, but bisphosphonates should only be taken once a month on a specific day of the treatment cycle or 7 days apart from the study drug infusions.
  • Must have received at least three previous treatments aimed at prolonging life for metastatic disease, including at least one new-generation anti-androgen therapy, one or two taxane-containing regimens, and possibly other approved therapies for mCRPC.
  • Must have **progressive disease** at the time of entering the study, which means the cancer is getting worse, shown by either soft-tissue disease progression or bone disease progression, but not just an increase in PSA levels.

Who cannot join the trial?

3 criteria

  • Patients who do not have metastatic castrate resistant prostate cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population, such as those who cannot give informed consent, are excluded.
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Investigated drugs

PT-112 is an experimental medication being tested for its safety and effects in patients with advanced solid tumors. It is given through an intravenous injection. The study aims to find the best dose and schedule for using this medication in future studies. The goal is to see how well it can control the disease over a period of four months.

What is already known about the treatment

PT-112 – PT-112 is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors, including metastatic castrate-resistant prostate cancer. It is in the early stages of research, with ongoing studies to determine the optimal dosing schedule. The main therapeutic indication is for patients with advanced solid tumors, particularly those with prostate cancer that has not responded to other treatments. PT-112 works by disrupting cancer cell growth at the molecular level, although the exact mechanism is still under investigation. It is classified pharmacologically as an anti-cancer agent, specifically targeting tumor cells to inhibit their proliferation.

Investigated diseases

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. It is characterized by the cancer's ability to metastasize, or spread, to other parts of the body, such as bones and lymph nodes. The disease progresses despite hormonal therapy aimed at lowering testosterone, which is typically used to control prostate cancer growth. Patients may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. The progression of the disease is often monitored through imaging tests and blood markers like PSA (prostate-specific antigen) levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518506-41-00Protocol codePT-112-101Estimated enrolment109 patientsSponsorPromontory Therapeutics Inc.

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