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Study of High-Dose Radiation Therapy Combined with Goserelin for High-Risk Prostate Cancer Patients Using AI-Based Treatment Planning

Registered drugNo placebo

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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 patients with prostate cancer who will receive a combination of two treatments: radiotherapy and hormone therapy using goserelin. The hormone therapy involves using a medication that is given as an implant under the skin. The study aims to personalize treatment using advanced imaging techniques including PET/CT scans and artificial intelligence to determine the most appropriate treatment plan for each patient.

The treatment involves high-dose radiation therapy delivered in 6 sessions, specifically targeting the prostate. This is combined with androgen deprivation therapy (hormone treatment that reduces male hormone levels) using goserelin implants. The radiation treatment is guided by special scans that use a substance called PSMA (prostate-specific membrane antigen) to create detailed images of the prostate.

The study will use artificial intelligence to analyze various medical images and information to help determine the best treatment approach. This includes looking at special prostate scans called magnetic resonance imaging (MRI) along with other tests. The treatment period will last several months, during which patients will receive both radiation therapy and hormone treatment, and their progress will be monitored for several years afterward.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment Phase
You will receive hormone therapy (goserelin) through implantation to reduce testosterone levels
This treatment will be combined with targeted radiation therapy to the prostate
The radiation therapy will be delivered in 6 treatment sessions
Step 2
Treatment Monitoring
Your PSA levels will be regularly monitored
You will undergo periodic imaging scans (PSMA-PET/CT or MRI) to check treatment effectiveness
Regular assessment of side effects related to urinary and digestive systems will be conducted
Step 3
Quality of Life Assessment
You will complete questionnaires about your quality of life
These forms will assess urinary function, digestive health, and other aspects of daily living
Your testosterone levels will be monitored during recovery
Step 4
Long-term Follow-up
Your health status will be monitored for up to 5 years after treatment completion
Regular check-ups will include PSA testing and imaging scans as needed
Any changes in your health condition will be documented and addressed

Who can join the trial?

10 criteria

Patient must have confirmed prostate cancer through tissue examination (biopsy), with testing done preferably within the last 12 months
Must provide the prostate biopsy sample with the highest ISUP grade (a system that grades how aggressive the cancer appears under microscope)
Must have high-risk or very high-risk prostate cancer according to current medical guidelines
Cancer must be confined to the prostate as shown on special imaging tests (PSMA-PET and MRI scans)
Must provide signed informed consent to participate in the study
Must be over 18 years old
Must have previously undergone specific imaging tests: PSMA-PET/CT, detailed MRI, or PSMA-PET/MR
Must be classified as low or intermediate risk by artificial intelligence assessment
Must have good physical function status (ECOG score of 0 or 1, meaning able to carry out all or most daily activities)
Must have acceptable urinary symptoms (IPSS Score of 15 or less, which measures urinary problems)

Who cannot join the trial?

15 criteria

Prior radiation therapy to the pelvic area
Active inflammatory bowel disease (chronic conditions affecting the digestive tract such as Crohn's disease or ulcerative colitis)
History of hip replacement surgery
Presence of metastases (cancer that has spread to other parts of the body)
Inability to lie still for the required imaging and treatment procedures
Severe urinary symptoms requiring catheterization
Previous treatment with chemotherapy for prostate cancer
Presence of other active cancers (except for non-melanoma skin cancer)
Severe heart or lung disease that could interfere with treatment
Known allergies to contrast agents used in imaging
Mental conditions that could affect ability to provide informed consent
Participation in other clinical trials within the past 30 days
Female patients (study is specifically for male patients)
Age below 18 years
Contraindications to hormone therapy (treatment that affects male hormones)

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Investigated drugs

Based on the provided trial information, there are two main therapies involved: Androgen Deprivation Therapy (ADT) This is a hormonal therapy that reduces testosterone levels in the body. It's commonly used to treat prostate cancer by slowing down the growth of cancer cells that depend on testosterone to grow. Radiotherapy This is a targeted treatment that uses high-energy radiation beams to destroy cancer cells in the prostate. In this trial, it's being delivered in an ultra-hypofractionated format, which means higher doses are given over fewer treatment sessions (6 fractions), making the overall treatment time shorter for patients. The trial also uses PSMA PET/CT imaging for guidance, but this is a diagnostic tool rather than a treatment.

Goserelin

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, but the trial mentions androgen deprivation therapy (ADT), I will describe the common medications used in ADT for prostate cancer: Leuprolide - An injectable medication that belongs to the class of GnRH agonists, administered as regular shots (monthly, quarterly, or yearly) to lower testosterone levels in prostate cancer treatment. It works by initially stimulating and then suppressing the production of testosterone in the body, effectively slowing down the growth of prostate cancer cells. Goserelin - A hormone therapy medication delivered via subcutaneous implant that reduces testosterone production in men with prostate cancer. It belongs to the luteinizing hormone-releasing hormone (LHRH) agonist class and works by blocking signals from the brain that tell the testicles to produce testosterone. Bicalutamide - An oral anti-androgen medication taken daily as tablets that blocks the effects of testosterone on prostate cancer cells. It works by preventing testosterone from binding to androgen receptors in prostate cancer cells, helping to slow or stop cancer growth while being commonly used in combination with other forms of hormone therapy.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. The condition typically begins when normal prostate cells start to grow uncontrollably, forming a tumor. This cancer usually grows slowly in its early stages, and most cases develop in men over the age of 50. The disease can remain localized within the prostate or spread to nearby tissues. Prostate cancer often develops without noticeable early symptoms, and its progression can vary significantly between individuals.