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Study of Apalutamide and Androgen Deprivation Therapy for Patients with Metastatic Hormone-sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a condition known as metastatic hormone-sensitive prostate cancer (mHSPC). This type of cancer occurs when prostate cancer cells spread to other parts of the body and still respond to hormone therapy. The study is investigating the effectiveness of a treatment that combines a medication called Apalutamide with a standard treatment known as androgen deprivation therapy (ADT). Apalutamide is taken in the form of a film-coated tablet. The trial will compare this combination treatment to ADT alone to see if it can improve outcomes for patients with mHSPC.

The purpose of the study is to determine if adding Apalutamide to ADT can help patients live longer or delay the progression of their cancer as seen on imaging tests. Participants in the study will be randomly assigned to receive either the combination of Apalutamide and ADT or ADT with a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will receive regular monitoring to assess their health and the progression of their cancer. The study is expected to last for several years, allowing researchers to gather comprehensive data on the long-term effects of the treatment. The ultimate goal is to find out if the combination of Apalutamide and ADT can provide better outcomes for patients with metastatic hormone-sensitive prostate cancer compared to ADT alone.

1 joining the study

Upon joining the study, the participant is randomly assigned to one of two groups: one receiving apalutamide plus androgen deprivation therapy (ADT), and the other receiving a placebo plus ADT.

The study is designed to be double-blind, meaning neither the participant nor the researchers know which group the participant is in.

2 treatment administration

Participants in the apalutamide group receive the medication in the form of a film-coated tablet, taken orally.

The dosage and frequency of administration are determined by the study protocol and are monitored by the research team.

Participants in the placebo group receive a similar-looking tablet without the active medication.

3 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor their health and the effectiveness of the treatment.

These assessments include imaging tests to evaluate radiographic progression-free survival (rPFS) and overall survival (OS).

Additional evaluations may include monitoring for pain progression, skeletal-related events, chronic opioid use, and the need for cytotoxic chemotherapy.

4 completion of the study

The study is estimated to conclude by December 1, 2026.

Upon completion, data from the study will be analyzed to determine the efficacy of apalutamide in combination with ADT compared to ADT alone.

Who Can Join the Study?

  • Must have a confirmed diagnosis of prostate adenocarcinoma, which is a type of prostate cancer.
  • Must have cancer that has spread to other parts of the body, shown by at least one bone lesion on a special bone scan. If there is only one bone lesion, it must be confirmed by a CT or MRI scan.
  • Must have an ECOG Performance Status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
  • If the participant received docetaxel treatment, they must have:
    • Received no more than 6 cycles of docetaxel for their cancer.
    • Received the last dose of docetaxel within 2 months before joining the study.
    • Shown stable disease or better response to docetaxel, as assessed by imaging and PSA tests, before joining the study.
  • Other treatments for cancer that are allowed:
    • Only one course of radiation or surgery is allowed, and radiation for cancer that has spread must be completed before joining the study.
    • Up to 6 months of androgen deprivation therapy (ADT) before joining the study.
  • Previous treatments for localized prostate cancer must have been completed at least 1 year before joining the study, including:
    • Up to 3 years total of ADT.
    • Any other treatments like radiation, prostate removal, lymph node removal, and other therapies.
  • Only male participants are eligible for the study.

Who Cannot Join the Study?

  • Patients who have a different type of cancer that is not metastatic hormone-sensitive prostate cancer. This means the cancer has spread to other parts of the body and still responds to hormone therapy.
  • Patients who are female, as the study is only for male participants.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

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 Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Spitalul Clinic Prof.Dr.Theodor Burghele Bucharest Romania
Oncolab S.R.L. Craiova Romania
Hospital Universitario Reina Sofía Cordoba Spain
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Krajska nemocnice Liberec a.s. Liberec Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
16.11.2015
Romania Romania
Not recruiting
16.11.2015
Spain Spain
Not recruiting
16.11.2015

Trial locations

Investigated drugs:

Apalutamide is a medication used in this trial to treat metastatic hormone-sensitive prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. The study aims to see if adding Apalutamide to standard hormone therapy can improve the time patients live without their cancer getting worse or increase their overall survival.

Androgen Deprivation Therapy (ADT) is a standard treatment for prostate cancer that reduces the levels of male hormones in the body. These hormones can fuel the growth of prostate cancer cells. ADT is used in this trial as a baseline treatment to compare the effects of adding Apalutamide.

Investigated diseases:

Metastatic Hormone-sensitive Prostate Cancer – This is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The disease begins in the prostate gland and can metastasize to bones, lymph nodes, or other organs. It is characterized by the cancer cells’ sensitivity to hormones, meaning they can be controlled or slowed by reducing hormone levels. Over time, the cancer may progress despite hormone therapy, leading to increased symptoms and complications. The progression is often monitored through imaging studies to assess changes in tumor size or spread. As the disease advances, patients may experience symptoms such as bone pain or urinary issues.

Trial ID:
2023-508607-20-00
Protocol code:
56021927PCR3002
Trial Phase:
Therapeutic confirmatory (Phase III)

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