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Study on Bicalutamide and Drug Combination for Patients with Unfavorable Intermediate/High-Risk Prostate Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying prostate cancer, specifically in patients with unfavorable intermediate or high-risk levels. The treatment being tested involves the use of Bicalutamide, a medication that acts as a non-steroidal antiandrogen. This means it helps block the effects of male hormones that can promote the growth of cancer cells. In this study, Bicalutamide is administered through the mouth, specifically by placing it against the cheek, a method known as buccal use.

The purpose of the study is to evaluate the effectiveness of the treatment over a period of three years. Participants will be randomly assigned to different groups to compare the outcomes of using Bicalutamide with other treatment options. The study aims to determine if the survival rate without evidence of disease is significantly different between the groups. If no significant difference is found, the treatment without additional drugs will be considered for future comparisons with standard care.

Throughout the study, participants will be monitored for overall survival and other health outcomes. The trial is designed to provide valuable information on the potential benefits of using Bicalutamide in treating prostate cancer, helping to guide future treatment decisions for patients with this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals diagnosed with unfavorable intermediate or high-risk prostate cancer. Eligibility is based on specific medical criteria, including a confirmed diagnosis of prostate adenocarcinoma and a performance status that allows participation.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of bicalutamide, a medication used to manage prostate cancer. This medication is taken through the mouth, specifically by placing it against the cheek, a method known as buccal use.

    The dosage and frequency of bicalutamide administration are determined by the study protocol and are designed to align with the treatment objectives.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the effectiveness of the treatment. This includes evaluating the primary objective, which is the 3-year survival without biochemical evidence of disease (bNED).

    Secondary assessments focus on overall survival rates and other health indicators relevant to the study.

  4. Step 4

    Completion of the study

    The study is expected to conclude by March 8, 2026. At this point, final evaluations are conducted to determine the outcomes of the treatment and its impact on survival rates.

    The results will inform future treatment comparisons and potential adjustments to standard care practices.

Who can join the trial?

6 criteria

  • Must be a male patient.
  • Must have been diagnosed with **prostate adenocarcinoma**, which is a type of prostate cancer.
  • The cancer should be classified as **intermediate risk (IR)** or **high risk (HR)** according to the **NCCN definition**, which is a guideline used by doctors to assess cancer risk.
  • The cancer should not have spread to the lymph nodes or other parts of the body, as shown by specific imaging tests like **choline PET-CT** or **PSMA PET-CT**.
  • Must have an **ECOG performance status** between 0 and 2, which is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means capable of self-care but unable to work.
  • Must be within the age range of 18 to 65 years old.

Who cannot join the trial?

3 criteria

  • Patients who do not have unfavorable intermediate/high risk prostate cancer cannot participate. This means the study is only for those with a specific level of prostate cancer risk.
  • Only male patients are eligible. Female patients cannot participate in this study.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups of people who might need special protection or care.
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Investigated drugs

  • Stereotactic Body Radiation Therapy (SBRT)

    is a type of radiation therapy that delivers high doses of radiation to a targeted area, such as a tumor, with precision. It is used in this trial to treat prostate cancer by focusing radiation directly on the cancer cells, minimizing damage to surrounding healthy tissue.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones, or androgens, in the body to slow the growth of prostate cancer. In this trial, it is used in combination with SBRT to evaluate its effectiveness in improving survival outcomes for patients with intermediate to high-risk prostate cancer.

What is already known about the treatment

Leuprolide – Leuprolide is administered as an injection, typically given under the skin or into a muscle. It is currently well-established in medical literature as a treatment for prostate cancer, particularly in patients with unfavorable intermediate or high-risk profiles. The main therapeutic indication for leuprolide is to manage hormone-sensitive prostate cancer by reducing testosterone levels. At the molecular level, leuprolide acts as a gonadotropin-releasing hormone (GnRH) agonist, which initially increases and then significantly decreases the production of testosterone. It is classified pharmacologically as a hormone therapy agent.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, difficulty in urination, or blood in the urine. The cancer can spread to nearby tissues or other parts of the body, such as bones or lymph nodes. The risk of developing prostate cancer increases with age, and it is more common in men over 50. Factors like family history and certain genetic changes can also increase the risk.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511886-12-00Protocol code2020-004195-17Estimated enrolment146 patientsSponsorI.F.O. Istituti Fisioterapici Ospitalieri

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