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Study on the Effect of Degarelix and Ultrasound Therapy for Patients with Intermediate-Risk Prostate Cancer

Verified siteRegistered drugNo 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 intermediate-risk prostate cancer, a type of cancer that occurs in the prostate gland, which is part of the male reproductive system. The treatment being investigated is called Degarelix, which is a medication used to lower the levels of certain hormones in the body that can affect prostate cancer growth. The study also involves a procedure known as MRI-guided transurethral ultrasound ablation (TULSA), which uses sound waves to target and treat the prostate gland.

The purpose of this study is to explore how short-term treatment with Degarelix affects the prostate and tumor characteristics as seen on an MRI scan, and to understand the combined effects of Degarelix and the TULSA procedure on treatment outcomes. Participants will first receive Degarelix to see how it changes the prostate and tumor before undergoing the TULSA procedure. The study will then assess the impact of combining these treatments on the prostate cancer and overall health outcomes.

Throughout the study, various aspects will be monitored, such as changes in the size of the prostate and tumor, the contact length between the tumor and surrounding tissues, and blood flow to the prostate and tumor. These will be measured using different types of MRI scans. The study will also evaluate the safety and effectiveness of the treatment combination over a period of five years, looking at both cancer-related outcomes and quality of life for the participants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, the patient will attend an initial visit where the study details will be explained. The patient must understand the study and sign the informed consent documents in the presence of designated staff.
Step 2
Pre-treatment assessment
The patient will undergo a series of assessments to confirm eligibility, including a review of medical history, physical examination, and imaging tests such as MRI to evaluate prostate and tumor characteristics.
Step 3
Administration of <b>degarelix</b>
The patient will receive a subcutaneous injection of degarelix, a medication used to manage prostate cancer. The dosage and frequency will be determined by the study protocol.
Step 4
Monitoring and follow-up
The patient will have regular follow-up visits to monitor the effects of the medication. This includes MRI scans to measure changes in prostate and tumor volume, as well as other assessments to evaluate the impact of the treatment.
Step 5
MRI-guided transurethral ultrasound ablation (TULSA)
After the pre-treatment period, the patient will undergo the TULSA procedure, which is a treatment that uses ultrasound to target and treat the prostate gland.
Step 6
Post-treatment evaluation
Following the TULSA procedure, the patient will have additional follow-up visits to assess the treatment's effectiveness and monitor for any side effects. This includes further MRI scans and other evaluations as required by the study.
Step 7
Long-term follow-up
The patient will be monitored for a period of up to 5 years to evaluate the long-term safety and effectiveness of the treatment, as well as its impact on quality of life.

Who can join the trial?

10 criteria

Must be a male aged 40 years or older and a candidate for radical prostate cancer treatment.
Must be able to speak and understand Finnish, English, or Swedish and be willing to sign the informed consent documents.
Must have an estimated life expectancy of more than 8 years.
Must have at least one MRI-visible tumor that matches a biopsy result, with a Prostate Imaging–Reporting and Data System (PI-RADS) score of 3 or higher.
Must have biopsy-confirmed, intermediate-risk localized prostate cancer with specific clinical or radiological stages and biopsy obtained between 6 weeks and 12 months before treatment.
Must have a PSA level of 20 ng/ml or less. PSA is a protein produced by the prostate gland, and its level is checked through a blood test.
Must not have had any prior definitive treatment for prostate cancer.
Must be eligible for MRI, which is a type of scan that uses magnetic fields to create detailed images of the body.
Must be eligible for general anesthesia, which is a medically induced state of unconsciousness, classified as American Society of Anesthesiologists Class III or less.
Patients taking 5-alpha reductase inhibitors (5-ARIs), which are medications that affect hormone levels, are eligible if they stopped using them 12 months before and throughout the study period.

Who cannot join the trial?

3 criteria

Patients who do not have intermediate-risk prostate cancer cannot participate.
Only male patients are eligible for the study.
Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.

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Turku University Hospital
Turku, Finland

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Investigated drugs

Degarelix
is a medication used in this clinical trial to help manage prostate cancer. It works by reducing the levels of certain hormones in the body, which can slow down or stop the growth of cancer cells. In this study, Degarelix is given before a procedure called MRI-guided transurethral ultrasound ablation (TULSA) to see how it affects the prostate and tumor characteristics. The goal is to understand if using Degarelix before the procedure can improve the treatment outcomes for patients with intermediate-risk prostate cancer.
TULSA
, or MRI-guided transurethral ultrasound ablation, is a therapy used in this trial to treat prostate cancer. It involves using ultrasound waves, guided by MRI, to precisely target and destroy cancerous tissue in the prostate. This procedure is minimally invasive, meaning it doesn't require large incisions, and aims to treat the whole prostate gland. The study is exploring how well this therapy works when combined with the medication Degarelix, to see if the combination can lead to better treatment results for patients.

Degarelix

What is already known about the treatment

Degarelix – Degarelix is administered as an injection under the skin, typically in the abdominal area. It is currently used in medicine to treat prostate cancer, particularly in patients with intermediate-risk prostate cancer, as part of a clinical trial exploring its effects when combined with MRI-guided ultrasound treatment. The main therapeutic indication for Degarelix is to lower testosterone levels, which can help slow the growth of prostate cancer. At the molecular level, Degarelix works by blocking the signals from the brain that tell the body to produce testosterone, effectively reducing its levels. It is classified as a gonadotropin-releasing hormone (GnRH) antagonist in pharmacology.

Investigated diseases

Intermediate-risk prostate cancer – Intermediate-risk prostate cancer is a type of prostate cancer that is characterized by specific clinical features, such as a moderately elevated prostate-specific antigen (PSA) level, a Gleason score of 7, or a tumor that is palpable but confined to the prostate. This stage of prostate cancer indicates a moderate likelihood of progression compared to low-risk or high-risk categories. The disease typically progresses by growing within the prostate and may eventually spread to nearby tissues or lymph nodes if not managed. The growth rate can vary, and the cancer may remain asymptomatic for some time. Over time, changes in the prostate and tumor characteristics can be observed through imaging techniques like MRI, which help in assessing the progression.