Study on High-Intensity Focused Ultrasound and Leuprorelin Acetate for Intermediate Risk Prostate Cancer Patients

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What is this study about?

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 study is exploring a combination treatment that includes High-Intensity Focused Ultrasound (HIFU) and a short-term therapy called androgen deprivation therapy (ADT). HIFU is a technique that uses high-frequency sound waves to target and destroy cancer cells, while ADT is a treatment that reduces male hormones, which can help slow the growth of prostate cancer.

The purpose of this study is to evaluate how effective this combination treatment is in controlling prostate cancer and to observe its impact on functions such as erectile and ejaculatory functions, as well as urinary continence. Participants in the study will receive the treatment and be monitored over a period of time to assess these outcomes. The study will also look at the levels of certain substances in the blood, like prostate-specific antigen (PSA) and testosterone, which are important indicators of prostate health.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes assessing their quality of life and any potential side effects or complications from the treatment. The study aims to provide valuable information on the effectiveness and safety of using HIFU and ADT together for treating intermediate-risk prostate cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Blood tests are performed to measure prostate specific antigen (PSA) levels and other relevant markers.

2 treatment planning

A treatment plan is developed, which includes the use of ELIGARD 22.5 mg, a medication administered as a subcutaneous injection (under the skin).

The medication is given to help manage prostate cancer by reducing levels of male hormones.

3 medication administration

ELIGARD 22.5 mg is administered as a single injection. The effects of the medication are monitored over time.

The injection is part of a short-term treatment plan to assist in controlling prostate cancer.

4 HIFU treatment

High-Intensity Focused Ultrasound (HIFU) treatment is performed. This procedure targets and treats specific areas of the prostate affected by cancer.

The goal of HIFU is to destroy cancerous tissue while preserving surrounding healthy tissue.

5 follow-up assessments

Follow-up assessments are scheduled at 1, 3, 6, and 12 months after treatment. These assessments include blood tests to monitor PSA and testosterone levels.

Additional evaluations are conducted to assess erectile function, urinary continence, and overall quality of life.

6 final evaluation

A final evaluation is conducted 12 months after the HIFU treatment to determine the success of the treatment.

The evaluation includes a review of any remaining cancerous tissue and the need for any further interventions.

Who Can Join the Study?

Men aged 40 and over
Prostate volume must be 60 ml or less. If the prostate volume is between 40 ml and 60 ml, the cancer must be located in the back part of the prostate.
Must not have received any previous treatment for prostate cancer.
Men who are sexually active with women who can become pregnant must use a highly effective method of birth control before starting hormonal therapy and continue for 130 days after the last treatment.
Must have localized intermediate-risk prostate cancer.
Must have a PI-RADS score of 3 or higher on an MRI scan. PI-RADS is a way to describe how likely it is that a prostate lesion is cancerous based on MRI results.
Must have cancer on one side of the prostate or both sides, but with a Gleason score of 3+3 on the untreated side. Gleason score is a grading system used to evaluate the aggressiveness of prostate cancer.
Must have a Gleason score of 7 (3+4), which is considered ISUP grade 2. ISUP is a grading system for prostate cancer.
Prostate-specific antigen (PSA) level must be 15 ng/ml or less. PSA is a protein produced by the prostate, and high levels can indicate prostate cancer.
Must be in clinical stage cT1c-T2b. This refers to the size and extent of the cancer within the prostate.
Must not have cancer that has spread outside the prostate or into the seminal vesicles. Seminal vesicles are glands that help produce semen.
Must not have cancer that has spread to lymph nodes or other parts of the body.

Who Cannot Join the Study?

Patients who are not male cannot participate.
Patients who do not have intermediate risk prostate cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Irozdwie Mrzwflulbc Mbfnbxohym	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	07.03.2023

Trial locations

Investigated drugs:

Leuprorelin Acetate

High-Intensity Focused Ultrasound (HIFU) is a therapy that uses focused sound waves to generate heat and destroy cancer cells in a specific area of the prostate. In this trial, HIFU is used to target and treat only the part of the prostate affected by cancer, which is known as hemi-ablation. This approach aims to control the cancer while minimizing damage to the surrounding healthy tissue, potentially preserving important functions like urinary continence and sexual function.

Androgen Deprivation Therapy (ADT) is a treatment that reduces the levels of male hormones, such as testosterone, in the body. These hormones can help prostate cancer cells grow, so lowering their levels can slow down or shrink the cancer. In this trial, ADT is used for a short period alongside HIFU to enhance the control of prostate cancer. The combination of these therapies aims to improve the effectiveness of the treatment for patients with intermediate-risk localized prostate cancer.

Intermediate-risk localized prostate cancer – This form of prostate cancer is characterized by cancer cells that are confined to the prostate gland but have features that suggest a moderate risk of progression. The cancer cells may grow more quickly than low-risk prostate cancer, but they have not yet spread to other parts of the body. Over time, the cancer may grow and potentially spread beyond the prostate if not managed. The progression can lead to symptoms such as difficulty urinating, blood in the urine, or pelvic discomfort. The risk level is determined by factors such as PSA levels, Gleason score, and the extent of cancer found in biopsy samples. Monitoring and assessment are crucial to understanding how the disease is evolving.

Trial ID:

2024-518680-36-00

Protocol code:

ENHANCE

NCT ID:

NCT03845751

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on High-Intensity Focused Ultrasound and Leuprorelin Acetate for Intermediate Risk Prostate Cancer Patients

What is this study about?

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