Study on Radiotherapy and Antiandrogens for Patients with Advanced Prostate Cancer Using Abiraterone Acetate and Enzalutamide

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What is this study about?

This clinical trial is focused on studying a condition known as castration-resistant prostate cancer, which is a type of prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. The study is specifically looking at patients with a limited number of cancer spread sites, referred to as oligometastatic. The treatment being tested combines a type of precise radiation therapy called fractionated stereotactic radiotherapy with medications known as second-generation antiandrogens. These medications include Abiraterone and Enzalutamide, which are taken as film-coated tablets.

The purpose of the study is to understand how well this combination treatment works in delaying the progression of the cancer as seen on special imaging tests like choline PET/CT or 68Ga-PSMA PET/CT. The study will follow patients over a period of time to see how long they live and how their quality of life is affected. It will also monitor any side effects they might experience from the treatment.

Participants in the study will receive either Abiraterone or Enzalutamide, as decided by their doctor, along with the specialized radiation therapy. The treatment will be given for a maximum period of 36 months. The study aims to provide valuable information on the effectiveness and safety of combining these treatments for patients with this specific type of prostate cancer.

1 initiation of treatment

Begin taking the prescribed medication, which may be either abiraterone acetate or enzalutamide. These medications are taken orally in the form of film-coated tablets.

The dosage for abiraterone acetate is 500 mg per tablet, while enzalutamide is 80 mg per tablet. The specific dosage and frequency will be determined by the responsible physician based on clinical routine.

2 monitoring and assessment

Undergo regular monitoring to assess the response to the treatment. This includes radiological evaluations using choline PET/CT or 68Ga-PSMA PET/CT scans to check for any progression of the disease.

The main objective is to determine the progression-free survival (PRFS) from the start of the second-generation antiandrogen treatment to any radiological progression.

3 stereotactic radiotherapy

Receive fractionated stereotactic radiotherapy (SBRT) if eligible. This treatment is targeted at specific areas where cancer has spread, such as bone or lymph node metastases.

Eligibility for SBRT is based on the size and location of the metastases, as confirmed by radiological imaging.

4 ongoing evaluation

Continue with regular assessments to monitor overall survival and quality of life. These assessments may include questionnaires validated for oncology patients.

Monitor for any acute or chronic side effects using the Common Terminology Criteria for Adverse Events (CTCAEv5.0) scale.

5 completion of trial

The trial is expected to continue until July 3, 2028. Participation will involve ongoing treatment and assessments until the trial’s conclusion or until the responsible physician advises otherwise.

Who Can Join the Study?

Patients must have a type of prostate cancer called prostate adenocarcinoma, confirmed by a biopsy.
There must be a biochemical progression of the cancer, which means changes in blood tests that show the cancer is growing, confirmed by specific criteria called the Phoenix criteria. The testosterone level should be at castration levels, which means less than 50 ng/ml or 1.7 nmol/L.
The cancer must be confirmed by a special scan (choline-PET/CT or 68Ga-PSMA PET/CT) to have no more than 5 areas of spread to lymph nodes or bones, but not to other organs. The areas in the bones should be less than 3 cm, and in the lymph nodes less than 5 cm, and they should be suitable for a treatment called SBRT (a type of precise radiation therapy).
Patients should be suitable to receive treatment with medications called abiraterone or enzalutamide, as decided by their doctor before joining the study.
Patients must agree to participate by signing a written consent form.
Patients should have a life expectancy of more than 3 months.

Who Cannot Join the Study?

Patients who do not have oligometastatic castration-resistant prostate cancer. This means the cancer has spread to a few other parts of the body and does not respond to treatments that lower testosterone.
Patients who are not male. This study is only for male participants.
Patients who are not within the specified age range. The study is for certain age groups, so if you are too young or too old, you may not be eligible.
Patients who belong to a vulnerable population. This means people who might need special protection or care, like those with certain disabilities or conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario De Cruces	Barakaldo	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Universitario Rey Juan Carlos	Mostoles	Spain
Holnsruk Dz Lp Smrpm Cqmp I Srbh Pcz	Barcelona	Spain
Iczkoawf Clnbpe Dpuncxwxfrlxrapsy	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	03.10.2023

Trial locations

Investigated drugs:

Second-generation antiandrogen is a type of medication used in this trial to treat patients with castration-resistant prostate cancer. It works by blocking the effects of male hormones that can promote the growth of prostate cancer cells. This medication is part of the treatment combination being studied to see if it can help delay the progression of the disease.

Fractionated stereotactic radiotherapy (SBRT) is a form of radiation therapy used in this trial. It involves delivering high doses of radiation to specific areas of the body where cancer has spread, known as oligometastases. The therapy is given in several smaller doses, or fractions, to minimize damage to surrounding healthy tissue. This treatment is combined with the second-generation antiandrogen to evaluate its effectiveness in controlling cancer progression.

Investigated diseases:

Hormone-refractory prostate cancer

Castration-Resistant Prostate Cancer – This is a form of prostate cancer that continues to progress despite the reduction of testosterone to very low levels, which is typically achieved through medical or surgical means. The disease is characterized by the cancer’s ability to grow even when the amount of testosterone in the body is reduced to castrate levels. It often involves the spread of cancer cells to other parts of the body, a condition known as metastasis. Patients with this type of cancer may experience symptoms related to the spread of cancer, such as bone pain or urinary issues. The progression of the disease can be monitored using imaging techniques like PET/CT scans.

Trial ID:

2023-505024-62-01

Protocol code:

IRA-RAD-2022-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Radiotherapy and Antiandrogens for Patients with Advanced Prostate Cancer Using Abiraterone Acetate and Enzalutamide

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?