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Study of vinorelbine and cisplatin with radiation therapy for patients with castration- and taxane-resistant prostate cancer

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What is this trial about?

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

This study focuses on treating advanced prostate cancer that has stopped responding to hormone therapy and standard chemotherapy treatments. The research examines a treatment combination using two chemotherapy drugs - vinorelbine and cisplatin, along with targeted radiation therapy guided by special imaging called PSMA-PET/CT. This type of cancer is known as castration-resistant and taxane-resistant prostate cancer, meaning it continues to grow despite previous treatments with hormone therapy and common chemotherapy drugs.

The purpose of this study is to determine if combining these chemotherapy drugs with precisely targeted radiation therapy (called stereotactic ablative radiotherapy) can help control cancer that has spread to a limited number of locations in the body. The treatment involves receiving chemotherapy through an intravenous infusion, along with radiation therapy directed at specific tumor sites identified through specialized imaging scans.

This is a two-phase study where doctors first evaluate the safety of this treatment combination, and then assess how well it works at controlling the cancer. The study is designed for patients who have already tried other standard treatments and have limited remaining treatment options. The treatment approach aims to target both widespread disease with chemotherapy and specific tumor sites with focused radiation therapy.

The research process

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

Step 1
Initial assessment
Your medical history and current condition will be evaluated to confirm eligibility for the study.
A PSMA-PET/CT scan will be performed to assess the location and extent of cancer.
Step 2
Treatment phase 1: Chemotherapy
You will receive two medications through intravenous infusion:
Cisplatin and vinorelbine will be administered according to the determined sequence.
The treatment schedule and specific dosages will be provided by your healthcare team.
Step 3
Treatment phase 2: Targeted radiation therapy
Stereotactic ablative radiotherapy (SABR) will be administered to specific areas identified by the PET/CT scan.
This precise radiation treatment targets individual cancer sites.
The radiation therapy schedule will be determined based on your specific condition.
Step 4
Monitoring and follow-up
Regular assessments will track your response to treatment.
Monitoring includes physical examinations and imaging scans.
PSA level measurements will be taken to assess treatment effectiveness.
Side effects and safety will be closely monitored throughout the study.
Step 5
Study completion
The study is expected to continue until December 2026.
Final evaluations will assess the overall effectiveness of the treatment combination.

Who can join the trial?

9 criteria

You must be a male aged 40 years or older
You must provide written consent to participate in the study
You must have prostate adenocarcinoma (a type of prostate cancer) confirmed by tissue examination. Patients with other types of prostate cancer are not eligible
Your physical condition must meet ECOG Performance Status of 0-2 (ability to perform daily activities with minimal assistance)
Your cancer must be resistant to both hormone therapy (treatments like abiraterone or enzalutamide) and chemotherapy (treatments like docetaxel or cabazitaxel), with evidence that the disease has gotten worse despite these treatments
Your disease progression must be confirmed by either:
- Changes visible on imaging tests (CT scan or bone scan), or
- Three consecutive blood tests showing rising PSA levels (a protein indicating prostate cancer activity), with at least a 2 ng/mL increase
- You must have completed any previous cancer treatments at least 4 weeks before starting the study
- You must have tried all available standard treatments, with no other treatment options remaining, as determined by a team of cancer specialists

Who cannot join the trial?

15 criteria

Prior allergic reactions to vinorelbine or cisplatin (chemotherapy medications used in this study)
Severe heart conditions or uncontrolled heart disease
Active infections requiring treatment
Significant kidney problems (as cisplatin can affect kidney function)
Severe liver dysfunction
Other active cancers (except non-melanoma skin cancer)
Uncontrolled high blood pressure
Brain metastases (cancer spread to the brain) that are not treated
Serious psychiatric conditions that could interfere with study participation
Unable to follow study procedures or attend scheduled visits
Participation in another clinical trial within the past 30 days
Female patients (study is specifically for male patients)
Age under 18 years
Severe bone marrow problems affecting blood cell production
History of serious bleeding disorders

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Verified sites

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Tartu University Hospital
Tartu, Estonia

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Investigated drugs

Vinorelbine is a chemotherapy medication used to treat cancer. It belongs to a class of drugs called vinca alkaloids, which work by stopping cancer cells from dividing and growing. In this trial, it is being tested as part of a treatment combination for advanced prostate cancer that has become resistant to other treatments. Cisplatin is a widely used chemotherapy drug that fights cancer by damaging the DNA in cancer cells, preventing them from multiplying. It is being tested in combination with vinorelbine for patients whose prostate cancer has stopped responding to hormone therapy and other chemotherapy treatments. Docetaxel is a chemotherapy medication belonging to the taxane family. While not part of the new treatment being tested, it is mentioned as one of the previous treatments that patients in the trial would have already received. It works by interfering with cell division. Cabazitaxel is another taxane chemotherapy drug that patients in the trial would have previously received. Like docetaxel, it works by disrupting cancer cell division, and is typically used when other treatments have stopped working. Stereotactic Ablative Radiotherapy (SABR) is a highly precise form of radiation therapy that delivers high doses of radiation to specific tumor sites. In this trial, it is guided by PSMA-PET/CT imaging to target metastatic prostate cancer lesions accurately.

What is already known about the treatment

Vinorelbine
A chemotherapy medication administered intravenously or orally that belongs to the vinca alkaloid class of drugs, which works by preventing cancer cells from dividing and growing. In this clinical trial, it is being studied in combination with cisplatin for treating advanced prostate cancer that has become resistant to both hormone therapy and taxane chemotherapy. The drug interferes with microtubule formation in cells, effectively blocking cell division and tumor growth.
Cisplatin
A platinum-based chemotherapy drug given through intravenous infusion that works by binding to DNA in cancer cells, preventing them from dividing and ultimately leading to cell death. This well-established anticancer medication is being investigated in combination with vinorelbine for treating advanced prostate cancer that has not responded to standard treatments. The drug is classified as an alkylating agent and has been a cornerstone of cancer treatment for several decades.
Docetaxel
An intravenously administered chemotherapy medication from the taxane family that works by disrupting the microtubule network essential for cell division and function. This medication is mentioned as part of the previous standard treatment that patients in the trial have already received for their prostate cancer. The drug stabilizes microtubules in cancer cells, preventing them from dividing and ultimately leading to cell death.
Cabazitaxel
A newer-generation taxane chemotherapy drug administered intravenously that is specifically designed to work in cases where cancer has become resistant to other taxane medications. This drug is referenced as one of the previous treatments that trial participants have already received, and it works by preventing cancer cells from dividing by disrupting their internal structural framework. The medication is specifically approved for use in advanced prostate cancer that has progressed after other treatments.

Investigated diseases

Prostate Cancer – A disease that develops in the prostate gland of the male reproductive system. It typically begins with slow-growing changes in prostate cells, which can eventually form tumors. The cancer usually progresses gradually, first remaining within the prostate gland, but may later spread to surrounding tissues. As the disease advances, it can become resistant to standard hormonal treatments, a state known as castration-resistant prostate cancer. The condition often develops in older men and may initially cause no noticeable symptoms. The cancer cells can form metastases, spreading to other parts of the body, particularly to bones and lymph nodes.