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Study on Prostate Cancer: Comparing Stereotactic Body Radiation Therapy Alone or with Triptorelin and Bicalutamide for Patients with Acinar Cell Prostatic Carcinoma

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 the treatment of prostate cancer, specifically a type called acinar cell prostatic carcinoma. The study is investigating the effects of a treatment called stereotactic body radiation therapy (SBRT), which is a precise form of radiation therapy that targets the prostate. The trial is examining whether adding androgen deprivation therapy (ADT) to SBRT improves outcomes for patients compared to using SBRT alone. ADT is a treatment that reduces male hormones, which can help slow the growth of prostate cancer.

Two medications are being used in this study. The first is Decapeptyl, which contains the active substance triptorelin and is administered as a prolonged-release injection under the skin. The second medication is Casodex, which contains the active substance bicalutamide and is taken orally as a film-coated tablet. These medications are part of the ADT treatment being tested in combination with SBRT.

The purpose of the study is to determine if there is an improvement in the time patients remain free from signs of cancer after treatment, known as biochemical disease-free survival (bDFS). Participants in the study will receive either SBRT alone or SBRT combined with ADT. The trial will monitor patients over time to assess the effectiveness of these treatments in preventing cancer recurrence and improving overall survival. The study is expected to continue until 2029.

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

    Initial treatment phase

    The trial involves two groups: one receiving stereotactic body radiation therapy (SBRT) alone and the other receiving SBRT combined with androgen deprivation therapy (ADT).

    If assigned to the group receiving ADT, the medication triptorelin is administered as a subcutaneous injection. This is a prolonged-release suspension for injection, given every six months.

    Additionally, the medication bicalutamide is taken orally in the form of a film-coated tablet. The dosage is 50 mg daily.

  2. Step 2

    Radiation therapy

    The stereotactic body radiation therapy (SBRT) is administered to the prostate. This is a precise form of radiation therapy aimed at targeting the cancer cells while minimizing exposure to surrounding healthy tissue.

  3. Step 3

    Monitoring and follow-up

    Regular follow-up appointments are scheduled to monitor the response to treatment. This includes imaging tests and blood tests to measure prostate-specific antigen (PSA) levels.

    The primary goal is to determine if there is an improvement in biochemical disease-free survival (bDFS), which is assessed by monitoring PSA levels.

  4. Step 4

    Completion of trial

    The trial is expected to continue until November 28, 2029. During this time, ongoing assessments will be conducted to evaluate the effectiveness of the treatment.

    Secondary outcomes include disease-free survival, freedom from local and regional recurrence, freedom from distant metastasis, and overall survival.

Who can join the trial?

12 criteria

  • Age between 18 and 80 years old.
  • Prostate size must be less than 100 cubic centimeters (cc).
  • PSA, a blood test for prostate health, must be done within 60 days before joining the study.
  • No cancer spread to lymph nodes or other parts of the body, as shown by specific scans like PET or CT scans.
  • Confirmation of prostate acinar adenocarcinoma, a type of prostate cancer, with at least 10 samples taken during a biopsy.
  • Undergo a special MRI scan of the prostate to check the local stage of cancer.
  • Belong to the intermediate unfavorable group based on certain risk factors, such as specific PSA levels, cancer grade, or percentage of positive biopsy samples.
  • Belong to a specific high-risk group based on certain criteria like cancer stage or PSA levels.
  • Have an ECOG performance status of 0-2, which means the patient is fully active or has some limitations but can still take care of themselves.
  • Ability to understand and sign a written consent form agreeing to participate in the study.
  • Willingness to complete questionnaires about their health during the study.
  • Have an IPSS score between 0 and 15, which measures urinary symptoms.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are under 18 years old or over 65 years old cannot participate in the study.
  • Patients with medical conditions other than Acinar cell prostatic carcinoma cannot participate. This is a specific type of prostate cancer.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Stereotactic Body Radiation Therapy (SBRT)

    is a type of radiation therapy that precisely targets cancer cells in the prostate. It uses advanced imaging techniques to deliver high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. This therapy is used to treat prostate cancer and aims to improve the control of the disease.

  • Androgen Deprivation Therapy (ADT)

    is a treatment that reduces the levels of male hormones, such as testosterone, in the body. These hormones can promote the growth of prostate cancer cells. By lowering hormone levels, ADT can help slow down or shrink the cancer, making it an important part of prostate cancer treatment.

What is already known about the treatment

Androgen Deprivation Therapy (ADT) – This treatment is typically administered through injections or oral medications and is used to lower levels of male hormones that can fuel the growth of prostate cancer cells. In medical literature, ADT is well-established as a standard treatment for prostate cancer, particularly in advanced stages. It is primarily indicated for conditions like acinar cell prostatic carcinoma. The mechanism of action involves reducing the production of androgens, such as testosterone, or blocking their effects on cancer cells, thereby slowing or stopping tumor growth. ADT is classified under hormonal therapies, specifically as an anti-androgen or androgen synthesis inhibitor.

Investigated diseases

Acinar cell prostatic carcinoma – This is a type of prostate cancer that originates in the acinar cells, which are responsible for producing the fluid part of semen. It is the most common form of prostate cancer. The disease typically progresses slowly, often without noticeable symptoms in the early stages. As it advances, it may cause urinary difficulties, such as increased frequency or difficulty in urination. In some cases, it can spread to other parts of the body, including bones and lymph nodes. The progression and symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520093-34-00Protocol codeASST-FRADIO-SPA-2020Estimated enrolment310 patientsSponsorAzienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

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