Study on High-Risk Prostate Cancer Treatment Using Darolutamide, Relugolix, and Drug Combination for Eligible Patients

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What is this study about?

This clinical trial is focused on studying the treatment of prostate cancer, a disease that affects the prostate gland in men. The study will explore the effectiveness of different treatments, including a medication called darolutamide (also known by its code name BAY 1841788), which is an androgen receptor inhibitor. Androgens are male hormones that can promote the growth of prostate cancer cells. The trial will also involve other treatments such as relugolix, leuprorelin acetate, goserelin acetate, degarelix, and docetaxel. These medications work in various ways to manage hormone levels or directly target cancer cells. A placebo will also be used in some parts of the study.

The purpose of the study is to determine if these treatments can improve outcomes for patients with high-risk prostate cancer. The study will be conducted in two parts. The first part will focus on intensifying treatment to see if it can prevent the spread of cancer as detected by a special imaging test called PSMA PET/CT. The second part will look at whether a less intense treatment approach can maintain or improve the quality of life for patients. Participants will receive treatment for up to 96 weeks, which is about 24 months, and their progress will be monitored over time.

Throughout the study, participants will undergo various assessments to track their health and the effectiveness of the treatments. These assessments will include regular imaging tests and questionnaires to evaluate their quality of life. The study aims to provide valuable insights into the best ways to treat high-risk prostate cancer and improve the lives of those affected by this condition.

1 joining the study

Upon joining the study, participation in a clinical trial for high-risk prostate cancer begins. The trial is designed to evaluate new diagnostic and treatment methods.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status, focusing on prostate cancer diagnosis and risk factors.

3 treatment phase 1

The first phase of treatment involves the administration of Orgovyx 120 mg film-coated tablets, taken orally. This medication is used to manage hormone levels and is taken daily.

4 treatment phase 2

In the second phase, Docetaxel is administered as an intravenous infusion. This treatment is given every three weeks for a total of six cycles, aiming to target cancer cells directly.

5 treatment phase 3

The third phase includes the use of Darolutamide, taken orally. This medication is part of a combination therapy to enhance treatment effectiveness and is taken twice daily.

6 monitoring and follow-up

Regular monitoring through PSMA PET/CT scans is conducted to assess treatment progress. These scans help in detecting any new lesions or changes in the cancer’s status.

7 quality of life assessments

Quality of life is evaluated using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. This assessment occurs annually to monitor the impact of treatment on daily life.

8 completion of trial

The trial concludes after the specified treatment period, with a final assessment to evaluate overall health and treatment outcomes. Long-term follow-up may be recommended based on individual needs.

Who Can Join the Study?

The patient must have prostate cancer confirmed by a test called histopathology.
The patient must have high-risk disease, which means having any of the following: a PSA level greater than 20 ng/mL, a T-stage of 3 or 4, or a Gleason score between 8 and 10. PSA is a protein made by the prostate, T-stage describes the size and extent of the main tumor, and the Gleason score indicates how aggressive the cancer is.
The patient must have an ECOG Performance Status of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must be willing to have a PSMA PET/CT scan, which is an imaging test that helps to see cancer spread, with or without a special dye called contrast.
The patient must agree to have their main tumor tested to find out the Decipher score, which helps predict the behavior of the cancer.
The patient must be willing to undergo SOC RT (standard of care radiation therapy) and long-term ADT (androgen deprivation therapy), which may include treatment with darolutamide and/or LHRHA. ADT is a treatment to lower male hormones that can help prostate cancer grow.
The patient must be male.

Who Cannot Join the Study?

Only male participants are allowed, so females cannot participate.
Participants must be within certain age ranges, so those outside these ranges cannot join.
Individuals with certain vulnerabilities or special needs are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
CHU Helora	La Louviere	Belgium
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Vitaz	Sint-Niklaas	Belgium
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Azorg	Aalst	Belgium
Cseypoegx Uodgqjmzbhagvi Sicjhjjqh	Woluwe-Saint-Lambert	Belgium
Htasvftb Da Ld Svwwf Cnlo I Swdj Pxp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2023
Spain	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Darolutamide 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, darolutamide is being tested to see if it can improve the quality of life and effectiveness of treatment when used alongside standard care.

Standard of Care Radiation Therapy (SOC RT) is a common treatment for prostate cancer that uses high-energy rays to target and kill cancer cells. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with high-risk prostate cancer.

Androgen Deprivation Therapy (ADT) is a treatment that reduces the levels of male hormones in the body to slow down or stop the growth of prostate cancer. It is often used as a standard treatment for prostate cancer and is being compared in this trial to see if adding other therapies can improve patient outcomes.

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. In advanced stages, it may spread to bones or other parts of the body. The progression can vary greatly, with some cases remaining localized and others becoming more aggressive.

Trial ID:

2022-501551-90-00

Protocol code:

CTO21042GZA

Trial Phase:

Therapeutic use (Phase IV)

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Study on High-Risk Prostate Cancer Treatment Using Darolutamide, Relugolix, and Drug Combination for Eligible Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?