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Study on Apalutamide and Hormone Therapy Before Surgery for Patients with Advanced High-Risk Prostate Cancer

Verified siteInvestigationalNo 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 a treatment for patients with locally advanced T4 high-risk prostate cancer. The treatment being investigated involves the use of a medication called Apalutamide, which is taken in the form of a film-coated tablet. This medication is combined with another treatment known as Androgen Deprivation Therapy (ADT), which helps to lower the levels of male hormones that can promote cancer growth.

The purpose of the study is to assess whether this combination treatment can make surgery possible for patients who initially have tumors that are considered inoperable. The study will involve taking the medication for up to six months before undergoing a surgical procedure called a radical prostatectomy, which is the removal of the prostate gland. During the study, participants will be monitored through various methods, including MRI scans and clinical examinations, to determine the effectiveness of the treatment in making the cancer operable.

Participants will be observed for any changes in their condition, including the response of the cancer to the treatment and any side effects experienced. The study will also look at the overall health and quality of life of the participants, using tools like the FACT-P score, which measures the impact of prostate cancer on well-being. The trial aims to provide valuable information on the potential benefits of using Apalutamide and ADT before surgery in patients with this type of prostate cancer.

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 required to sign an informed consent form. This form indicates understanding of the study's purpose and procedures and willingness to participate.
The patient must meet specific criteria, such as being male, aged 18 to 80, and having a confirmed diagnosis of locally advanced T4 high-risk prostate cancer.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes a physical examination, laboratory tests, and imaging studies like MRI to evaluate the prostate cancer stage.
The patient's ability to swallow tablets and overall health status will be assessed to ensure they can undergo the treatment and subsequent surgery.
Step 3
Treatment phase
The patient will begin treatment with apalutamide, a medication taken orally in the form of film-coated tablets. This treatment is combined with androgen deprivation therapy (ADT).
The treatment duration is up to 6 months, with the possibility of extension if necessary. The goal is to reduce the tumor size and make surgery possible.
Step 4
Monitoring and evaluation
Throughout the treatment phase, the patient will have regular check-ups to monitor progress. This includes blood tests to measure prostate-specific antigen (PSA) levels and other health indicators.
Imaging studies and clinical examinations will be conducted to assess the tumor's response to treatment and determine operability.
Step 5
Surgery preparation
If the tumor becomes operable, the patient will be prepared for radical prostatectomy, a surgical procedure to remove the prostate gland.
The surgery is expected to occur within 6 to 9 months after starting the study treatment, depending on the patient's response.
Step 6
Post-surgery follow-up
After surgery, the patient will have follow-up visits to monitor recovery and check for any complications. This includes evaluating PSA levels to ensure complete biochemical remission.
The patient's quality of life and overall health will be assessed using questionnaires and health status scores.

Who can join the trial?

12 criteria

Must be a male between 18 to 80 years old.
Must agree to wear a condom during any activity that could pass ejaculate to another person while on the study drug and for 3 months after the last dose.
Must agree not to donate sperm for reproduction during the study and for at least 90 days after the last dose of the study drug.
Must sign an Informed Consent Form (ICF) to show understanding of the study's purpose and procedures and willingness to participate.
Must have a confirmed diagnosis of adenocarcinoma of the prostate without certain specific features.
Must have a specific type of prostate cancer called cT4, which is considered inoperable due to a fixed mass confirmed by an MRI scan.
Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1, indicating they are fit and willing to undergo surgery within 6 to 9 months after starting the study treatment.
Must have adequate organ function as shown by specific laboratory tests, including liver enzymes and platelet count.
Must have stopped using 5-alpha reductase inhibitors and estrogens at least 4 weeks before joining the study.
Must not have had irradiation of the pelvis.
Must be able to swallow whole tablets of the study drug.
Must not be a candidate for radiotherapy or must have declined radiotherapy.

Who cannot join the trial?

3 criteria

Patients who do not have locally advanced T4 high risk prostate cancer cannot participate. This means the cancer must be at a specific advanced stage and considered high risk.
Only male patients are eligible to participate. Female patients cannot join 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 harm.

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Verified sites

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

Universitaetsklinikum Aachen AöR
Verified
Aachen, Germany
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie
Verified
Homburg, Germany

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Investigated drugs

Apalutamide
is a medication used in this trial to help treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells. In this study, Apalutamide is given to patients before they undergo surgery to remove the prostate, with the aim of making the surgery more effective.
ADT
, or Androgen Deprivation Therapy, is another treatment used in this trial. It reduces the levels of male hormones in the body, which can help shrink the prostate cancer or slow its growth. ADT is often used in combination with other treatments, like Apalutamide, to improve the chances of successful treatment. In this study, ADT is used alongside Apalutamide before surgery to see if it helps make the cancer more manageable for removal.

Apalutamide

What is already known about the treatment

Apalutamide – Apalutamide is administered orally in the form of tablets and is currently being studied for its effectiveness in treating patients with locally advanced T4 high-risk prostate cancer. It is used in combination with androgen deprivation therapy (ADT) to potentially improve the operability of prostate cancer before surgery. Apalutamide works by blocking the action of male hormones, like testosterone, which can promote the growth of prostate cancer cells. It belongs to a class of drugs known as anti-androgens, which help slow down or stop the growth of cancer cells by interfering with hormone signals.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, it can spread to nearby tissues and organs, such as the bladder or rectum. In advanced stages, it may metastasize to distant parts of the body, including bones and lymph nodes. The progression of prostate cancer can vary, with some forms growing slowly and others advancing more rapidly. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort, but early stages often present no symptoms.