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Study on the Effect of Adding Leuprorelin Acetate to Radiotherapy for Patients with Oligo-recurrent Prostate Cancer with Up to 4 Metastases

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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 who have experienced a return of the disease after their initial treatment. The study is examining the effectiveness of adding a short-term hormonal treatment called Androgen Deprivation Therapy (ADT) to targeted radiotherapy. The medication used in this trial is called Eligard, which contains the active substance leuprorelin acetate. This treatment is administered as an injection.

The purpose of the study is to determine if combining ADT with radiotherapy can help delay the progression of cancer in patients with a limited number of metastases, which are small areas where the cancer has spread. Participants in the study will receive either the combination of ADT and radiotherapy or radiotherapy alone. The study will last for a period of six months, during which the effects of the treatments will be monitored.

The main goal is to see if the combination treatment can extend the time patients remain free from further cancer spread. Additionally, the study will look at other factors such as the quality of life, the time until further treatment is needed, and the overall survival of the patients. The trial will also assess the sensitivity of imaging techniques like PSMA-PET/CT or PSMA-PET/MRI used to detect cancer spread. The study is expected to conclude by the end of 2025.

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, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    A PSMA-PET/CT or PSMA-PET/MRI scan is required within 60 days prior to randomization to assess the presence of metastases.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving targeted radiotherapy alone, and the other receiving targeted radiotherapy combined with short-term hormonal treatment.

  3. Step 3

    Treatment phase

    For those in the combination group, the hormonal treatment involves the administration of leuprorelin acetate.

    The medication is given as an injection, specifically a solution for injection, known as Eligard 22.5 mg.

    This treatment is administered over a period of 6 months.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for metastases progression-free survival over a period of 2 years.

    Secondary outcomes such as PSA progression, quality of life, and clinical progression-free survival are also assessed.

    Regular follow-up appointments are scheduled to monitor health status and any potential side effects.

  5. Step 5

    End of study

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

    Final assessments are conducted to evaluate the effectiveness of the treatment and its impact on disease progression.

Who can join the trial?

9 criteria

  • Must have a confirmed initial diagnosis of **adenocarcinoma of the prostate**. This means the type of prostate cancer was identified through a tissue sample.
  • Must have a **biochemical recurrence** of prostate cancer after initial treatment. This means the cancer has returned, as shown by specific blood test results, after treatments like surgery or radiation.
  • Can have a maximum of 4 cancer spots in bones and lymph nodes, but no cancer in other organs. This is checked using a special scan called **PSMA-PET**.
  • Must be over 18 years old.
  • Must have had a **PSMA-PET/CT** or **PSMA-PET/MRI** scan within 60 days before joining the study. These are special imaging tests to look for cancer.
  • Must have a **PSA** level less than 10 ng/ml. PSA is a protein measured in the blood to check for prostate cancer activity.
  • If taking **finasteride** regularly, the PSA level should be less than 5 ng/ml. Finasteride is a medication that can affect PSA levels.
  • Must have a **WHO performance status** of 0-2. This is a scale that measures how well a person can perform daily activities.
  • Must sign an informed consent form before joining the study. This means agreeing to participate after understanding the study details.

Who cannot join the trial?

3 criteria

  • Patients who have more than 4 areas where cancer has spread, known as **metastases**.
  • Patients who are not male, as the study is only for male participants.
  • Patients who are considered part of a **vulnerable population**, which means they might need special protection or care.
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Investigated drugs

  • Androgen Deprivation Therapy (ADT)

    is a treatment used to reduce levels of male hormones, such as testosterone, which can stimulate the growth of prostate cancer cells. In this trial, ADT is being tested to see if it can help prolong the time before prostate cancer spreads further when used in combination with radiotherapy.

  • Metastasis-Directed Radiotherapy (MDRT)

    is a type of targeted radiation treatment aimed at specific areas where prostate cancer has spread. The goal of MDRT is to control or eliminate cancer cells in these specific locations, potentially improving outcomes for patients with oligo-metastatic prostate cancer.

What is already known about the treatment

Androgen Deprivation Therapy (ADT) – This medication is typically administered through injections or oral tablets, depending on the specific drug used within this therapy. It is currently a well-established treatment in medical literature for managing prostate cancer, particularly in cases where the cancer has recurred or spread to a limited number of sites. The main therapeutic indication for ADT is to reduce levels of male hormones, such as testosterone, which can fuel the growth of prostate cancer cells. At the molecular level, ADT works by either blocking the production of these hormones or preventing them from acting on cancer cells. It is classified under hormonal therapy, specifically as an anti-androgen or gonadotropin-releasing hormone (GnRH) agonist/antagonist.

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 spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The disease is typically detected through elevated prostate-specific antigen (PSA) levels or abnormal findings during a digital rectal exam. In some cases, prostate cancer can lead to urinary difficulties, pelvic discomfort, or erectile dysfunction. The progression of the disease varies, with some cases remaining localized while others develop metastases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511252-41-00Protocol codeRT2019-13Estimated enrolment280 patientsSponsorUniversitair Medisch Centrum Groningen

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