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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Tartu University Hospital	Tartu	Estonia

Trial status

Country	Status	Recruitment Start
Estonia	Not yet recruiting	01.06.2025

Trial locations

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.

Investigated diseases:

Prostate cancer

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.

Trial ID:

2025-521551-23-01

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

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