Study Comparing Degarelix and Drug Combination with Radiotherapy for Patients with High-Risk Localized or Locally Advanced Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for prostate cancer, specifically in cases where the cancer is very high risk and either localized or has spread locally. The study is comparing different types of hormone therapy used alongside radiotherapy. The hormone therapies being tested include a drug called degarelix, which is a GnRH antagonist, and other treatments like goserelin, triptorelin, and leuprorelin acetate, which are GnRH agonists. These treatments are used to lower levels of male hormones that can promote cancer growth.

The purpose of the study is to determine if using GnRH antagonists like degarelix can improve the time patients live without their cancer getting worse, compared to using GnRH agonists. Patients participating in the study will receive one of these hormone therapies in combination with radiotherapy. Some patients may receive a placebo. The study will follow patients over a period to monitor their health and any changes in their cancer status.

Participants will be monitored for various outcomes, including how long they live without the cancer progressing, the time until they need another type of cancer treatment, and their overall survival. The study will also look at the impact of these treatments on quality of life and any side effects, such as cardiovascular events or urinary tract infections. This research aims to provide better treatment options for patients with high-risk prostate cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either a GnRH antagonist or a GnRH agonist as part of their treatment plan. These medications are used to manage hormone levels in patients with prostate cancer.

2 treatment initiation

The patient will begin treatment with either degarelix (a GnRH antagonist) or a GnRH agonist such as goserelin, triptorelin, or leuprorelin acetate. The specific medication and dosage will be determined by the study protocol.

Degarelix is administered via subcutaneous injection, while goserelin and leuprorelin acetate are also given subcutaneously. Triptorelin is administered through intramuscular injection.

3 radiotherapy

In addition to the medication, the patient will receive external beam radiation therapy. This is a standard treatment for high-risk localized or locally advanced prostate cancer and is used in combination with hormone therapy to improve outcomes.

4 treatment duration

The treatment with hormone therapy will last for a minimum of 18 months if the patient is receiving primary treatment. If the patient is receiving adjuvant or early salvage irradiation after surgery, the hormone therapy will last for 6 months.

5 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of progression-free survival, which measures the time during and after treatment that the patient lives without the cancer progressing.

Secondary outcomes such as overall survival, prostate cancer-specific survival, and quality of life will also be evaluated.

6 study completion

The study is expected to conclude by December 31, 2025. At the end of the study, the collected data will be analyzed to determine the effectiveness of the treatments in improving patient outcomes.

Who Can Join the Study?

Patients can join the trial if they are in one of two situations: a) They are scheduled for primary treatment with radiation and at least 18 months of hormone therapy, or b) They had surgery in a specific study and are scheduled for additional radiation.
All patients must have normal levels of magnesium and potassium in their blood.
All patients must have a WHO Performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest.
All patients must be between 18 and 80 years old.
Patients with partners who can become pregnant must use effective birth control during the study and for at least 3 months after the last treatment dose.
All patients must provide written informed consent before joining the study, following specific guidelines and regulations.
For patients planned for primary radiotherapy: They must have a confirmed diagnosis of prostate cancer from a biopsy with at least 8 samples. They must have two of the following risk factors: PSA level of 20 or higher, a Gleason score of 8 or higher, certain lymph node involvement, or specific tumor stages.
For patients who had surgery in the specific study: They must have had the surgery within the past year and be scheduled for radiation and 6 months of hormone therapy if certain conditions are met, such as specific PSA levels or positive lymph nodes.
All patients must have no signs of cancer spread according to standard or modern imaging methods, or have limited spread (up to 3 lesions) that can be treated.
All patients must have a testosterone level of at least 200 ng/dL.
All patients must have adequate bone marrow function, which includes specific levels of white blood cells, hemoglobin, and platelets.
All patients must have adequate liver function, with specific limits on bilirubin and liver enzymes (AST and ALT).
All patients must have adequate kidney function, with a creatinine clearance of at least 50 mL/min.

Who Cannot Join the Study?

Patients who are not male cannot participate.
Patients who do not have a very high risk of localized or locally advanced prostate cancer cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who might not be able to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Pwxp Txfdf Hpomrkeu Utoxagtbtlrn	Sabadell	Spain
Iaiyauyp Clycws Dgxpjhznanzgjcbfm	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	16.11.2017
Germany	Not recruiting	16.11.2017
Spain	Not recruiting	16.11.2017

Trial locations

Investigated drugs:

GnRH Antagonist: This medication is used to lower the levels of certain hormones in the body, specifically those that can stimulate the growth of prostate cancer cells. In this trial, it is being tested to see if it can improve the time patients live without the cancer getting worse when used alongside radiation therapy.

GnRH Agonist: This medication also works to reduce hormone levels that can promote the growth of prostate cancer. It is typically used with another medication to prevent an initial increase in hormone levels, known as flare protection. The trial is comparing its effectiveness to that of the GnRH antagonist when used with radiation therapy.

External Beam Radiation Therapy: This is a type of treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is combined with hormone therapy to treat patients with high-risk localized or locally advanced prostate cancer. The goal is to see if this combination can help control the cancer more effectively.

Investigated diseases:

Prostate cancer

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It is often categorized by its risk level, such as very high risk localized or locally advanced, indicating the extent and aggressiveness of the cancer. In its localized form, the cancer is confined to the prostate, while locally advanced means it has spread to nearby tissues. The progression of prostate cancer can vary, with some cases growing slowly and others more rapidly. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort, but early stages often present no symptoms. The disease’s progression is monitored through various clinical measures, including PSA levels and imaging tests.

Trial ID:

2024-513450-30-00

Protocol code:

1414-ROG-GUCG

NCT ID:

NCT02799706

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Degarelix and Drug Combination with Radiotherapy for Patients with High-Risk Localized or Locally Advanced Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?