Study Comparing Docetaxel and Androgen Receptor-Targeted Agents (Abiraterone or Enzalutamide) for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is comparing two different treatment approaches for patients with this condition. One group of patients will receive Docetaxel, a chemotherapy drug given through an intravenous infusion, along with prednisone, a steroid medication. The other group will receive an Androgen Receptor-targeted agent, which could be either Abiraterone or Enzalutamide, both taken orally, also in combination with prednisone.

The purpose of the study is to determine if Docetaxel is more effective than the Androgen Receptor-targeted agents in treating patients with mCRPC who do not have mutations in the BRCA1/2 genes or whose mutation status is unknown. The study will look at how long patients live without their cancer getting worse, known as progression-free survival, and will also compare the overall survival rates and the safety of the treatments. Additionally, the study will assess the quality of life of patients using questionnaires designed to measure health-related quality of life.

Participants in the study will be randomly assigned to one of the two treatment groups and will receive their assigned treatment for a period of time. The study will monitor the patients’ health and response to the treatment through regular check-ups and tests. The trial aims to provide valuable information on the best first-line treatment options for patients with mCRPC who have certain adverse prognostic factors, which are characteristics that may predict a worse outcome for the patient.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive docetaxel or an androgen receptor-targeted agent such as abiraterone or enzalutamide.

2 treatment with docetaxel

If assigned to the docetaxel group, you will receive this medication through an intravenous infusion. This means the medication will be administered directly into your vein. You will also take prednisone orally. The treatment cycle is typically every three weeks, but your doctor will provide specific instructions.

3 treatment with androgen receptor-targeted agent

If assigned to the androgen receptor-targeted agent group, you will take either abiraterone or enzalutamide orally. You will also take prednisone orally. The dosage and frequency will be explained by your doctor, and you will follow this regimen as directed.

4 regular monitoring

Throughout the study, you will have regular appointments to monitor your health and the effectiveness of the treatment. This will include blood tests, imaging scans, and other assessments as needed. Your doctor will inform you about the schedule and any preparations required for these tests.

5 completion of the study

The study is expected to last until April 2027. Upon completion, you will have a final assessment to evaluate your health status and the outcomes of the treatment. Your doctor will discuss the results with you and provide guidance on any further steps or treatments if necessary.

Who Can Join the Study?

Willing and able to provide written informed consent.
Have adequate blood and chemistry values, which means:
- Hemoglobin (a protein in red blood cells) of at least 10.0 g/dL without needing a blood transfusion.
- Neutrophil count (a type of white blood cell) of at least 1500 x 10⁹/L.
- Platelet count (cells that help with blood clotting) of at least 100,000/μL.
- Serum albumin (a protein in the blood) of at least 3.5 g/dL.
- Serum creatinine (a waste product in the blood) less than 1.5 times the upper limit of normal, or a calculated creatinine clearance of at least 60 mL/min.
- Serum potassium (an important mineral) of at least 3.5 mmol/L.
- Liver function tests showing:
  - Serum bilirubin (a substance made by the liver) less than 1.5 times the upper limit of normal, except for patients with Gilbert’s disease.
  - AST or ALT (enzymes that indicate liver health) less than 2.5 times the upper limit of normal.
Able to swallow the study drug whole as a tablet.
Life expectancy of at least 6 months.
If you have a partner who can become pregnant, you must agree to use a method of birth control with adequate barrier protection during the study and for 13 weeks after the last dose of the study drug.
Male aged 18 years and above.
Have prostate cancer confirmed by a tissue sample.
Have cancer that has spread to other parts of the body, as shown by a bone scan or other imaging tests like CT or MRI. If the cancer has only spread to lymph nodes, the lymph nodes must be at least 2 cm in size. Alternatively, the spread can be confirmed by PET-Choline or PSMA scans.
Prostate cancer progression documented by PSA (a protein produced by the prostate) according to specific guidelines or by imaging tests.
Have at least one negative prognostic feature, such as:
- Mildly symptomatic prostate cancer with a pain score of 2 or 3 on a specific pain scale.
- Asymptomatic prostate cancer with a pain score of 0 or 1 and at least one of the following:
  - PSA level of 80 ng/dL or higher.
  - Gleason Score (a grading system for prostate cancer) of 8 or higher.
  - PSA doubling time of 3 months or less.
  - Time from starting hormone therapy to castration-resistant prostate cancer of less than 1 year.
No evidence of mutation in BRCA1 or BRCA2 genes, or tumor tissue not evaluated for quality reasons (status unknown).
Surgically or medically castrated, with testosterone levels of less than 50 ng/dL (less than 2.0 nM).
ECOG Performance Status (a scale to assess how a disease affects daily living abilities) of 0 or 2.

Who Cannot Join the Study?

Patients with metastatic castration-resistant prostate cancer that have mutations in the BRCA1/2 genes cannot participate. If the status of these genes is unknown, participation is also not allowed.
Only male patients can participate in the study.
Patients who are part of a vulnerable population are not eligible. This means individuals who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Ospedale Generale Provinciale Di Macerata	Macerata	Italy
Azienda Unita Sanitaria Locale Di Modena	Carpi	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Azienda Sanitaria Locale Cn2 Alba-Bra	Alba	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azbxtvn Oolyahxltnc Upjntsfermckg Pfvuv	Parma	Italy
Aoleazn Suiuafmoq Lzofnh Apekdqbi Srznqpl Lidparlsvecnir	L'aquila	Italy
Apgsigr Uwx Ikhcl Dv Rexqbo Embopk	Reggio Emilia	Italy
Akvyhlk Utfao Sfjbzmubm Lqkpgt Dz Bzcalou	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	31.03.2020

Trial locations

Investigated drugs:

Docetaxel is a type of chemotherapy medication used to treat various types of cancer. In this clinical trial, it is being tested to see if it is more effective than other treatments for patients with a specific type of prostate cancer. Docetaxel works by stopping cancer cells from growing and dividing, which can help slow down or stop the spread of the cancer.

Abiraterone is a medication used to treat prostate cancer by lowering the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so by reducing them, abiraterone can help slow down the progression of the disease. In this trial, it is combined with another medication to see how well it works compared to other treatments.

Prednisone is a steroid that is often used alongside other cancer treatments. It helps reduce inflammation and can also help manage some of the side effects of cancer treatment. In this trial, prednisone is used together with abiraterone to see if this combination is effective in treating prostate cancer.

Enzalutamide is another medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. This trial is testing enzalutamide to see if it is a better option compared to other treatments for patients with a certain type of prostate cancer.

Investigated diseases:

Hormone-refractory prostate cancer

Metastatic Castration-Resistant Prostate Cancer – This is a form of prostate cancer that continues to progress despite treatments that lower testosterone levels. It is characterized by the spread of cancer cells beyond the prostate gland to other parts of the body, such as bones or lymph nodes. The disease progresses as cancer cells grow and multiply, often leading to increased symptoms such as pain or difficulty urinating. Over time, the cancer may become resistant to hormone therapy, which is initially used to control its growth. As the disease advances, it can lead to more severe symptoms and complications due to the spread of cancerous cells. The progression of this cancer is typically monitored through imaging tests and blood markers.

Trial ID:

2024-518623-30-00

Protocol code:

RADAR-1 CRPC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Docetaxel and Androgen Receptor-Targeted Agents (Abiraterone or Enzalutamide) for Patients with Metastatic Castration-Resistant Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?