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Study on the Effectiveness of Triptorelin, Goserelin Acetate, and Enzalutamide in Patients with Oligorecurrent Hormone-Sensitive 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 prostate cancer, specifically a type called oligorecurrent hormone-sensitive prostate cancer. This condition occurs when prostate cancer returns after initial treatment and is characterized by having a limited number of metastases, which are cancerous growths that have spread to other parts of the body. The study aims to explore the effectiveness of different treatments in managing this type of cancer. The treatments being tested include a combination of metastasis-directed therapy (MDT) and hormone therapy, which may involve medications like triptorelin, goserelin acetate, leuprorelin acetate, degarelix, and enzalutamide (also known as MDV3100). These medications are designed to help control the cancer by targeting specific hormones or receptors involved in its growth.

The purpose of the study is to determine if adding short-term hormone therapy or androgen receptor targeted therapy (ARTA) to MDT can significantly extend the time patients remain free from more severe forms of prostate cancer. The study will involve regular monitoring of patients to track the progression of the disease and assess the effectiveness of the treatments. Participants will receive these treatments through injections or oral capsules over a period of several months, depending on the specific medication and treatment plan.

Throughout the study, patients will undergo various assessments, including imaging tests like PSMA PET-CT or PSMA PET-MRI, to evaluate the presence and progression of cancer. The study will also monitor the quality of life and any side effects experienced by participants. The ultimate goal is to find the most effective treatment strategy for managing oligorecurrent prostate cancer and improving patient outcomes.

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
Initial visit and consent
Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your voluntary participation.
During this visit, your medical history will be reviewed, and you will undergo a physical examination to ensure you meet the study's eligibility criteria.
Step 2
Treatment assignment
You will be randomly assigned to one of the treatment groups. This may include metastasis-directed therapy (MDT) alone or in combination with hormone therapy.
The specific treatment plan will be explained to you, including the medications you will receive and their administration schedule.
Step 3
Medication administration
If you are assigned to receive hormone therapy, you may be given medications such as triptorelin, goserelin acetate, leuprorelin acetate, or degarelix. These are administered as injections, either as a prolonged-release suspension or solution.
The frequency and dosage of these medications will depend on your specific treatment group. For example, Decapeptyl may be administered every 3 months, while Firmagon may be given monthly.
Step 4
Oral medication
If your treatment includes androgen receptor targeted therapy (ARTA), you may receive enzalutamide capsules. These are taken orally, typically once a day.
The study team will provide instructions on how to take this medication and any potential side effects to watch for.
Step 5
Follow-up visits
You will have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits may include physical exams, blood tests, and imaging studies.
Your quality of life will be assessed using questionnaires at various points, such as at the start of the study, the end of treatment, and during follow-up consultations at months 1, 3, 6, 12, and 24.
Step 6
End of treatment
At the end of the treatment period, you will have a final assessment to evaluate your response to the therapy.
The study team will discuss the results with you and provide guidance on any further care or follow-up needed.

Who can join the trial?

11 criteria

The patient must provide voluntary written informed consent, which means they agree to participate in the study after being fully informed about it.
The patient should not have any psychological, sociological, or geographical conditions that might prevent them from following the study protocol.
The patient must be presented at a multidisciplinary board meeting, and their inclusion in the trial needs approval by this board.
The patient must use highly effective methods of birth control, such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence, or have a partner who has had a vasectomy.
The patient must have a histologically proven initial diagnosis of prostatic adenocarcinoma, meaning the diagnosis was confirmed by examining tissue under a microscope.
The primary tumor must have been previously treated and controlled.
The patient must have a biochemical recurrence, which is defined by prostate-specific antigen (PSA) values greater than 0.2 ng/ml after surgery and radiotherapy, or a PSA value of 2 ng/ml above the lowest level after high-dose radiotherapy.
The patient must have oligorecurrent disease, which means having a maximum of 5 metastases (cancer spread) outside the brain, diagnosed using specific imaging techniques. Nodal disease (cancer in lymph nodes) can be included only if accompanied by other types of metastases, with a total of no more than 5 spots.
The patient's serum testosterone level must be within the normal range.
The patient must have a WHO performance status of 0-2, which is a measure of their ability to perform daily activities, with 0 being fully active and 2 being capable of self-care but unable to work.
The patient must be 18 years old or older.

Who cannot join the trial?

3 criteria

Patients who do not have oligorecurrent hormone-sensitive prostate cancer cannot participate. This means the cancer has returned in a limited number of places and still responds to hormone therapy.
Only male patients are eligible for this study.
Patients who are part of a vulnerable population are not eligible. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of being exploited.

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Verified sites

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Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Androgen Deprivation Therapy (ADT)
is a treatment used to lower the levels of male hormones, such as testosterone, in the body. These hormones can help prostate cancer cells grow, so reducing their levels can slow down or stop the growth of the cancer. In this trial, ADT is used for a short period, either for 1 month or 6 months, to see if it helps in controlling prostate cancer when combined with other treatments.
Androgen Receptor Targeted Therapy (ARTA)
is a type of treatment that blocks the action of male hormones, like testosterone, on prostate cancer cells. These hormones can promote the growth of cancer cells, so by blocking them, ARTA can help to slow down or stop the cancer from growing. This therapy is used in combination with other treatments in the trial to see if it improves outcomes for patients with prostate cancer.
Metastasis-Directed Therapy (MDT)
is a treatment approach that focuses on targeting and treating specific areas where cancer has spread, known as metastases. The goal of MDT is to control or eliminate these cancerous areas to prevent further spread and improve the patient's quality of life. In this trial, MDT is combined with other therapies to evaluate its effectiveness in managing prostate cancer that has spread to other parts of the body.

What is already known about the treatment

Androgen Receptor Targeted Therapy (ARTA) – This medication is administered orally and works by blocking the action of male hormones, like testosterone, which can promote the growth of prostate cancer cells. Currently, ARTA is a well-established treatment in medical literature for prostate cancer, particularly in cases where the cancer is sensitive to hormones. It is primarily used for treating oligorecurrent hormone-sensitive prostate cancer, which means the cancer has returned in a limited number of sites and still responds to hormone therapy. At the molecular level, ARTA binds to androgen receptors on prostate cancer cells, preventing the hormones from activating these receptors and thus slowing down or stopping the growth of the cancer. This medication falls under the pharmacological classification of anti-androgens.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms initially. As it advances, it can lead to difficulty urinating, blood in urine, or pelvic discomfort. The disease can spread to nearby tissues or distant parts of the body, such as bones and lymph nodes. Hormone-sensitive prostate cancer responds to treatments that lower testosterone levels. Over time, it may become castration-resistant, meaning it continues to grow despite low testosterone levels.