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Study Comparing Rezvilutamide and Bicalutamide with Hormone Therapy for Patients with Advanced Prostate Cancer

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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 treatments for metastatic hormone-sensitive prostate cancer, a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The study is comparing two different treatments. One treatment involves a medication called SHR3680, which is a non-steroidal selective androgen receptor antagonist, combined with androgen deprivation therapy (ADT). The other treatment uses a medication called Bicalutamide, also a non-steroidal antiandrogen, combined with ADT. Additionally, the study includes the use of Goserelin, which is administered as an implant and helps in reducing the levels of certain hormones in the body.

The purpose of the study is to determine if the combination of SHR3680 and ADT is more effective than the combination of Bicalutamide and ADT in improving the time patients live without the cancer getting worse, known as radiological progression-free survival, and overall survival. Participants in the study will receive one of these treatment combinations and will be monitored over a period to assess the effectiveness and safety of the treatments. The study will also look at other factors such as the time it takes for prostate-specific antigen (PSA) levels to rise, the time to the next bone-related event, and the time to the start of the next prostate cancer treatment.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the progress of the cancer. The study aims to provide valuable information on the best treatment options for patients with this type of prostate cancer, potentially leading to improved outcomes and quality of life for those affected by the disease.

The research process

The trial runs in 6 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, eligibility is confirmed based on criteria such as age, performance status, and specific characteristics of prostate cancer.

    The study involves treatment for metastatic hormone-sensitive prostate cancer with a high tumor load.

  2. Step 2

    Treatment initiation

    The treatment involves the use of SHR3680 combined with androgen deprivation therapy (ADT) or Bicalutamide combined with ADT.

    ADT is a treatment that reduces male hormone levels, either through medication or surgery.

  3. Step 3

    Medication administration

    The medications include Casodex 50 mg Film-coated Tablets taken orally and Zoladex 10.8 mg implant administered as an injection.

    The specific dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment in terms of radiological progression-free survival and overall survival.

    Additional assessments include time to PSA progression, time to the next bone-related event, and time to the start of the next anti-prostate cancer treatment.

  5. Step 5

    Safety evaluations

    Safety evaluations are performed to monitor any adverse effects of the treatment.

    The study aims to ensure the safety and well-being of participants throughout the trial.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by December 31, 2025.

    Upon completion, the results will be analyzed to determine the effectiveness of the treatment options.

Who can join the trial?

7 criteria

  • Must be a male aged 18 years or older.
  • Must have a good general health status, which is measured by a scale called the ECOG Performance Status. A score of 0-1 means the person is fully active or has some symptoms but can still do light work.
  • Must have a type of prostate cancer called adenocarcinoma, confirmed by tests. This type of cancer does not have certain features like neuroendocrine differentiation or small cell characteristics, which are specific types of cancer cell changes.
  • Must have a high amount of cancer in the body, shown by medical imaging tests. This means either:
  • At least 4 areas of cancer spread to the bones, with at least one area not in the pelvis or spine, as seen in a bone scan.
  • Cancer spread to organs other than lymph nodes, as seen in a CT or MRI scan.
  • Must plan to receive or continue a treatment called ADT (Androgen Deprivation Therapy) during the study. This involves either taking medication to lower hormone levels or having had surgery to remove the testicles.

Who cannot join the trial?

4 criteria

  • Patients who do not have **metastatic hormone-sensitive prostate cancer**. This means the cancer has not spread to other parts of the body and is not responsive to hormone therapy.
  • Patients with a **low tumor load**. This means the amount of cancer in the body is not high.
  • Female patients, as the study is only for male patients.
  • Patients who are considered part of a **vulnerable population**. This refers to groups of people who may need special protection or care.
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Investigated drugs

  • SHR3680

    is a medication being studied for its potential to treat metastatic hormone-sensitive prostate cancer. It is being tested in combination with androgen deprivation therapy (ADT) to see if it can improve the time patients live without their cancer getting worse and overall survival compared to another treatment.

  • Bicalutamide

    is a medication used in this study as a comparison to SHR3680. It is also combined with androgen deprivation therapy (ADT) to treat metastatic hormone-sensitive prostate cancer. The study aims to determine if SHR3680 is more effective than Bicalutamide when used with ADT.

What is already known about the treatment

  • SHR3680

    SHR3680 is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic hormone-sensitive prostate cancer with a high tumor load. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is to improve radiological progression-free survival and overall survival in patients with this type of cancer. SHR3680 works by inhibiting the action of androgens, which are hormones that can promote the growth of prostate cancer cells. It is classified as an anti-androgen medication.

  • Bicalutamide

    Bicalutamide is taken orally and is an established medication used in the treatment of metastatic hormone-sensitive prostate cancer. It is well-documented in medical literature and is commonly used in combination with androgen deprivation therapy (ADT). The primary therapeutic indication is to manage prostate cancer by blocking the effects of androgens, which can stimulate cancer cell growth. Bicalutamide functions as an anti-androgen, preventing these hormones from binding to their receptors in cancer cells.

Investigated diseases

Metastatic Hormone-Sensitive Prostate Cancer with High Tumor Load – This is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The cancer cells grow in response to male hormones, such as testosterone. In this condition, the tumor burden is high, meaning there is a large amount of cancer present in the body. The disease progresses as the cancer cells continue to grow and spread, despite initial responses to hormone therapy. Over time, the cancer may become resistant to hormone treatments, leading to further progression. The focus is on managing the disease to slow its spread and maintain quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515194-10-00Protocol codeSHR-3680-III-HSPCEstimated enrolment654 patientsSponsorJiangsu Hengrui Pharmaceuticals Co. Ltd.

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