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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Jean Perrin	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Imvdgcnl Brkqzqcs	Bordeaux	France
Btjyyhqc Urzpwmnsep Hzdcczbl Cqmnia	Besançon	France
Ibfiverq Pyuihbrycegkodm Compxq Cwwxet	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Imifoplatin

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.

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 ID:

2024-518506-41-00

Protocol code:

PT-112-101

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

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