Not recruiting

Study on Prostate Cancer Treatment: Comparing Goserelin Acetate, Leuprorelin Acetate, Degarelix, and Apalutamide in Patients with Biochemical Progression After Surgery

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 treatments for prostate cancer, a condition where cancer cells form in the tissues of the prostate. The study involves comparing different treatment approaches for patients who have experienced a rise in prostate-specific antigen (PSA) levels after undergoing surgery to remove the prostate, known as radical prostatectomy. The treatments being studied include a combination of salvage radiotherapy with androgen-deprivation therapy (ADT) using medications called LHRH agonists or antagonists, and an alternative treatment using an anti-androgen therapy with a medication called apalutamide, which is also known by its code name JNJ-56021927.

The purpose of the study is to compare the effects of these treatments on sexual function in patients. Participants will receive one of the treatments for a period of six months. The study will monitor the participants' health and any changes in their condition, focusing on their sexual function nine months after starting the hormonal treatment. The study will also look at other aspects of quality of life and any side effects that may occur during the treatment period.

In addition to apalutamide, the study involves several other medications: ZOLADEX Long Acting (containing goserelin acetate), DEPO-ELIGARD (containing leuprorelin acetate), FIRMAGON (containing degarelix), and Decapeptyl Sustained Release (containing triptorelin). These medications are administered through injections or as tablets, depending on the specific treatment plan. The study aims to provide valuable insights into the effectiveness and impact of these treatments on patients' lives.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide informed consent to participate.
Step 2
Randomization
The patient will be randomly assigned to one of two treatment groups. One group will receive androgen-deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, and the other group will receive anti-androgen therapy (AAT) with apalutamide.
Step 3
Treatment initiation
The patient will begin the assigned treatment. If in the ADT group, the patient will receive either goserelin acetate, leuprorelin acetate, degarelix, or triptorelin via subcutaneous or intramuscular injection. If in the AAT group, the patient will take apalutamide orally.
Step 4
Treatment duration
The treatment will last for 6 months. During this period, the patient will continue to receive the assigned medication according to the specified route and dosage.
Step 5
Follow-up visits
The patient will attend scheduled follow-up visits at 0, 3, 6, and 9 months. These visits will include assessments of prostate-specific antigen (PSA) levels and other health evaluations.
Step 6
Assessment of outcomes
At 9 months, the patient's sexual function will be evaluated using the EPIC-26 sexual domain score. Quality of life and any side effects will also be assessed using standardized questionnaires.

Who can join the trial?

18 criteria

Must be a male over 18 years old.
Serum albumin level must be at least 3.0 grams per deciliter (g/dL). Serum albumin is a protein in your blood.
Serum creatinine must be less than 2 times the upper limit of normal. Creatinine is a waste product in your blood.
Serum potassium level must be at least 3.5 millimoles per liter (mmol/L). Potassium is a mineral in your blood.
Serum total bilirubin must be no more than 1.5 times the upper limit of normal. Bilirubin is a substance made during the breakdown of red blood cells. If you have Gilbert’s syndrome, further tests may be needed.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be less than 2.5 times the upper limit of normal. These are enzymes that help check liver function.
Medications that can lower the seizure threshold must be stopped or changed at least 4 weeks before joining the study. The seizure threshold is the level at which your brain might have a seizure.
Must agree to use a condom and another effective birth control method if having sex with a woman who can become pregnant, or use a condom if having sex with a pregnant woman. Also, must agree not to donate sperm during the study and for 3 months after the last dose of the study drug.
Must have received the information sheet and signed the informed consent form, which means you understand the study and agree to participate.
Must be willing to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but do not need bed rest during the day.
Must have a histologically confirmed adenocarcinoma of the prostate, which means a specific type of prostate cancer confirmed by examining tissue under a microscope.
Must have had a previous radical prostatectomy (RP), which is surgery to remove the prostate gland, with specific stages (pT2-3, pN0 or pNx).
Must have a detectable PSA (Prostate-Specific Antigen) level with a confirmed rise at least 8 weeks after RP. PSA is a protein produced by the prostate gland.
Must have hormone-naive disease, meaning the cancer has not been treated with hormone therapy.
Must be able to take oral medication, which means you can swallow pills or tablets.
Hemoglobin level must be at least 9.0 grams per deciliter (g/dL) without needing a blood transfusion or growth factors in the last 3 months. Hemoglobin is a protein in red blood cells that carries oxygen.
Platelet count must be at least 100,000 per microliter (µL) without needing a blood transfusion or growth factors in the last 3 months. Platelets are cells that help your blood clot.

Who cannot join the trial?

3 criteria

Individuals who do not have prostate cancer cannot participate. Prostate cancer is a type of cancer that occurs in the prostate, a small gland in men that produces seminal fluid.
Females are not eligible to participate in this study.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes people who may have limited ability to protect their own interests, such as children or those with certain disabilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Az St-Jan Brugge-Oostende A.V.
Verified
Brugge, Belgium
Gasthuiszusters Antwerpen
Verified
Antwerp, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

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Investigated drugs

LHRH Agonist
is a type of hormone therapy used to lower the levels of testosterone in the body. It works by signaling the pituitary gland to stop producing luteinizing hormone, which in turn reduces testosterone production by the testicles. This therapy is often used in the treatment of prostate cancer to slow the growth of cancer cells.
LHRH Antagonist
is another form of hormone therapy that directly blocks the receptors for luteinizing hormone-releasing hormone (LHRH) in the pituitary gland. This action quickly reduces testosterone levels in the body, which can help in managing prostate cancer by slowing down or stopping the growth of cancer cells.
Apalutamide
is an anti-androgen medication that works by blocking the action of androgens (male hormones) like testosterone. It prevents these hormones from stimulating prostate cancer cells, thereby slowing down or stopping their growth. Apalutamide is used in the treatment of prostate cancer, particularly in cases where the cancer has progressed despite other treatments.

What is already known about the treatment

Apalutamide – Apalutamide is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating prostate cancer. It is an anti-androgen medication that works by blocking the action of male hormones, such as testosterone, which can promote the growth of cancer cells. Apalutamide is classified as a non-steroidal anti-androgen and is used primarily for patients with prostate cancer who have experienced biochemical progression after surgery.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulties with urination, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression and symptoms can vary widely among individuals.