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Study of Apalutamide and Radiation Therapy for Patients with Low Burden Metastatic Hormone Sensitive 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 prostate cancer, specifically a type known as oligometastatic hormone-sensitive prostate cancer. This means the cancer has spread to a few other parts of the body but still responds to hormone therapy. The treatment being tested includes a medication called Apalutamide, which is taken as a film-coated tablet, and a type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a precise form of radiation that targets cancer cells while minimizing damage to surrounding healthy tissue.

The purpose of the study is to compare the effects of standard treatment with and without the addition of SBRT. Participants will be divided into two groups. One group will receive the standard treatment, which includes hormone therapy and Apalutamide. The other group will receive the same standard treatment plus SBRT to all sites where the cancer has spread. The study aims to see if adding SBRT can improve the rate of complete biochemical response, which is a measure of how well the cancer is controlled, at six months after starting treatment.

Participants will be monitored over a period of time to assess various outcomes, including the control of cancer spread, overall survival, and quality of life. The study will also track any side effects experienced by participants. This research hopes to provide valuable insights into whether combining these treatments can offer better outcomes for patients with this type of prostate cancer.

The research process

The trial runs in 5 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, you will be required to sign a written informed consent form. This document confirms your understanding of the study and your agreement to participate.

    You must be an adult aged 18 years or older with a specific type of prostate cancer known as oligometastatic hormone sensitive prostate cancer. This means you have up to 5 non-visceral metastatic lesions, which are areas where the cancer has spread.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two groups. One group will receive standard treatment, which includes androgen deprivation therapy (ADT) and a medication called apalutamide. The other group will receive the same treatment plus a type of radiation therapy called stereotactic body radiotherapy (SBRT) on all sites of metastatic disease.

  3. Step 3

    Medication administration

    If you are in the group receiving apalutamide, you will take this medication orally. The dosage and frequency will be determined by your healthcare provider based on your specific needs.

    The duration of the medication administration will be part of your treatment plan, and your healthcare provider will guide you through this process.

  4. Step 4

    Treatment monitoring

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular check-ups and tests to measure your prostate-specific antigen (PSA) levels, which help assess the effectiveness of the treatment.

    The primary goal is to achieve a complete biochemical response, defined as a PSA level of less than 0.2 ng/ml, within 6 months from the start of the treatment.

  5. Step 5

    Evaluation of outcomes

    Your progress will be evaluated based on several criteria, including freedom from biochemical and radiological progression, overall survival, and cancer-specific survival.

    Your quality of life will also be assessed using specific questionnaires designed to measure health-related quality of life.

Who can join the trial?

7 criteria

  • Patients who have signed a written informed consent form.
  • Adult patients who are 18 years or older.
  • Patients with oligometastatic hormone-sensitive prostate cancer, which means having 5 or fewer non-visceral (not involving major organs) metastatic lesions.
  • All cancer lesions must be treatable with stereotactic body radiotherapy (SBRT), a precise and high-dose form of radiation therapy, as determined by the treating radiation oncologist.
  • Patients who have had a return of cancer after previous surgery to remove the prostate (radical prostatectomy) or after definitive radiotherapy, as long as a radical approach on the prostate is administered.
  • Patients who started androgen deprivation therapy (ADT), a treatment to reduce male hormones, 6 months or less before joining the study.
  • Patients should be eligible to receive Apalutamide, a medication used to treat prostate cancer.

Who cannot join the trial?

3 criteria

  • Patients who do not have **prostate cancer**.
  • Patients who are not **male**.
  • Patients who are part of a **vulnerable population**. This means groups of people who might need special protection or care.
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Investigated drugs

  • Apalutamide

    is a medication used in this clinical trial to help treat prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down or stop the growth of cancer cells. In this study, Apalutamide is used alongside other treatments to see if it can improve the outcomes for patients with a specific type of prostate cancer.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones in the body. These hormones can help prostate cancer cells grow, so lowering their levels can help control the cancer. In this trial, ADT is used as part of the standard treatment for patients with prostate cancer to see how effective it is when combined with other therapies.

  • Stereotactic Body Radiotherapy (SBRT)

    is a type of radiation therapy that precisely targets cancer cells in the body. It delivers high doses of radiation to the cancer while minimizing damage to surrounding healthy tissue. In this study, SBRT is used to treat all sites of metastatic disease in patients, to see if it can improve the rate of complete biochemical response when added to the standard treatment.

What is already known about the treatment

Apalutamide – Apalutamide is a medication administered orally in the form of tablets. It is currently used in the treatment of prostate cancer, specifically for patients with metastatic hormone-sensitive prostate cancer. The main therapeutic indication for Apalutamide is to help manage prostate cancer by blocking the effects of male hormones that can promote the growth of cancer cells. At the molecular level, Apalutamide works by attaching to androgen receptors on cancer cells, preventing these hormones from stimulating cancer growth. It is classified as an androgen receptor inhibitor, which is a type of hormone therapy used in cancer treatment.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The progression can be slow, and some men may not experience symptoms for years. However, when symptoms do occur, they can include difficulty urinating, blood in urine, or pelvic discomfort. The disease can also lead to biochemical changes, such as increased levels of prostate-specific antigen (PSA) in the blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501894-37-00Protocol codePERSIANEstimated enrolment180 patientsSponsorFondazione Radioterapia Oncologica Onlus

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