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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Regione Del Veneto Azienda ULSS N 7 Pedemontana	Bassano Del Grappa	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Icrtor Icqswgpu Fnfxsaerslgcj Obuhlylfmxz	Rome	Italy
Ubjyhfoyqd Duugq Spisp Ds Rsef Li Skyvhnkm	Rome	Italy
Clao Dp Ctbp Afhfglkqkib Imtpyjqc Cxcoprfxvl Ogidcbyyxy Tbznsrvjurmkmj Mryir Pctksppt	Latina	Italy
Alkyxqq Ovbxciftlyn Ufsdarhjiuqxv Cntjvnhqgbgz Dpiyu Sltass E Dtmtn Sddalio Dq Tmkoig	Turin	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	12.07.2024

Trial locations

Investigated drugs:

Apalutamide

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.

Investigated diseases:

Prostate cancer metastatic

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.

Trial ID:

2024-515049-41-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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