Recruiting

Study on Surgical Treatment with or without Apalutamide for Patients with High-Risk Prostate Cancer Eligible for Radical Prostatectomy

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying metastatic prostate cancer, a type of cancer that begins in the prostate and can spread to other parts of the body. The study will explore the effects of a treatment involving a medication called apalutamide, also known by its code name ARN-509. Apalutamide is a nonsteroidal antiandrogen, which means it helps block the effects of male hormones that can promote cancer growth. The trial will compare the outcomes of patients receiving surgical treatment with or without apalutamide, alongside another treatment called ADT (androgen deprivation therapy), which reduces the levels of male hormones in the body.

The purpose of the study is to determine if adding apalutamide to the treatment plan improves the time patients live without their cancer worsening, as seen through a special imaging test called PSMA PET/CT. Participants in the study will be those who are candidates for a surgery called radical prostatectomy, which involves removing the prostate gland and some surrounding tissue. The study will follow participants over a period of time to observe the effects of the treatment, including any side effects and overall survival rates.

Throughout the study, participants will undergo regular assessments to monitor their health and the progression of their cancer. The trial aims to provide valuable information on whether the combination of apalutamide and ADT can offer better outcomes for patients with high-risk prostate cancer that has spread to a limited number of other areas, known as oligometastatic cancer. This research could potentially lead to improved treatment strategies for individuals facing this challenging condition.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, ability to receive hormone therapy, and health status.
A signed informed consent form is required, indicating understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted to confirm the diagnosis of high-risk prostate cancer and to evaluate the presence of low volume metastatic disease using PSMA PET/CT imaging.
Step 3
Treatment allocation
Participants are allocated to receive either surgical treatment alone or surgical treatment combined with apalutamide.
Apalutamide is administered in the form of 60 mg film-coated tablets, taken orally.
Step 4
Medication administration
If allocated to the combination treatment group, apalutamide is taken daily as prescribed by the study protocol.
The duration of apalutamide administration is determined by the study's requirements and the participant's response to treatment.
Step 5
Surgical procedure
Participants undergo a surgical procedure known as radical prostatectomy, which involves the removal of the prostate gland.
The procedure may include pelvic lymph node dissection (PLND) if deemed necessary.
Step 6
Post-surgery evaluation
Following surgery, participants are monitored for radiological progression-free survival using PSMA PET/CT imaging.
Additional evaluations include monitoring for adverse events and changes in health status.
Step 7
Follow-up and monitoring
Participants are followed up regularly to assess overall survival, progression-free survival, and any biochemical changes.
Quality of life is evaluated using specific questionnaires such as the Expanded Prostate Cancer Index (EPIC-26) and EQ-5D-5L.

Who can join the trial?

11 criteria

Must be a male between 18 and 79 years old.
Must be able to receive **ADT** (Androgen Deprivation Therapy) for at least 18 months, which is a treatment to lower male hormones, based on heart health and the doctor's assessment.
Must be able to swallow whole tablets of the study medication.
Must have signed a consent form indicating understanding of the study's purpose and procedures and willingness to participate, including following the study's rules and restrictions.
Must have a confirmed diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer.
Must have high-risk disease, defined by a **Gleason Sum Score** of 8 or higher, which is a grading system for prostate cancer.
Must have imaging tests showing no spread of cancer to other parts of the body.
Must have low volume metastatic disease, meaning a small amount of cancer spread, as shown by a specific type of scan called **PSMA PET/CT**.
Must be a candidate for **RP with PLND**, which means surgery to remove the prostate and nearby lymph nodes.
Must have an **ECOG Performance Status** score of 0 or 1, indicating full activity or some symptoms but nearly fully active.
Must have adequate organ function, meaning the organs are working well enough to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have metastatic prostate cancer cannot participate. This means the cancer has spread from the prostate to other parts of the body.
Only male patients are eligible, so female patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are considered part of a vulnerable population cannot participate. This usually refers to groups who may need special protection or care.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Verified
Turin, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Apalutamide
is a medication used in this trial to treat high-risk prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, it is being tested to see if it can improve outcomes when used alongside other treatments.
ADT (Androgen Deprivation Therapy)
is a treatment that reduces the levels of male hormones in the body, which can help slow the growth of prostate cancer. In this trial, ADT is used to see if it can improve results when combined with other therapies after surgery.

Apalutamide

What is already known about the treatment

Apalutamide – Apalutamide is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating high-risk prostate cancer, particularly in patients with metastatic prostate cancer. The main therapeutic indication for apalutamide is prostate cancer, where it works by blocking the action of male hormones that can promote the growth of cancer cells. At the molecular level, apalutamide acts as an androgen receptor inhibitor, preventing these receptors from stimulating cancer cell growth. It is classified pharmacologically as a non-steroidal antiandrogen.

Investigated diseases

Metastatic Prostate Cancer – This is a type of cancer that begins in the prostate gland and spreads to other parts of the body, such as bones or lymph nodes. It often progresses from localized prostate cancer when cancer cells break away and travel through the bloodstream or lymphatic system. As the disease advances, it can cause symptoms like bone pain, urinary issues, and fatigue. The progression of metastatic prostate cancer can vary, with some individuals experiencing rapid spread while others may have a slower progression. The disease is typically monitored through imaging tests and blood markers to assess the extent of spread and response to treatments.