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Study on Relugolix and Radiation Therapy for Patients with Intermediate 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 the treatment of intermediate risk prostate cancer. The treatment being tested involves a combination of a special type of radiation therapy called ultra-hypofractionated radiotherapy and an oral medication known as Relugolix, which is also referred to by its code name TAK-385. Relugolix is a type of medication that works by blocking certain hormones that can affect prostate cancer growth.

The purpose of the study is to see how well this combination treatment works in reducing the levels of a protein called PSA (prostate-specific antigen) in the blood, which is an indicator of prostate cancer activity. Participants in the study will receive a short course of oral Relugolix along with the radiation therapy over a period of six months. The study will also look at other outcomes, such as how long patients remain free from cancer returning, how quickly testosterone levels recover after treatment, and the impact on quality of life.

Throughout the study, researchers will monitor various aspects of health, including the occurrence of any fractures, cardiovascular events like heart attacks or strokes, and any changes in erectile function. The study aims to provide valuable information on the effectiveness and safety of this treatment approach for men with intermediate risk prostate cancer.

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

    Beginning of treatment

    Upon joining the study, the treatment begins with the administration of oral relugolix. This medication is taken by mouth.

    The dosage and frequency of relugolix will be provided by the healthcare team, and it is important to follow their instructions carefully.

  2. Step 2

    Radiotherapy sessions

    You will undergo ultra-hypofractionated radiotherapy, which involves receiving a total dose of 36.25 GY divided into 5 sessions.

    These sessions are scheduled over a short period, and the healthcare team will inform you of the exact dates and times.

  3. Step 3

    Monitoring and follow-up

    Throughout the treatment, regular monitoring will be conducted to assess your response. This includes measuring PSA levels to evaluate the effectiveness of the treatment.

    After 6 months, a complete biochemical response is defined as a PSA level of less than 0.5 ng/ml.

  4. Step 4

    Post-treatment evaluation

    Two years after the end of radiotherapy, an assessment will be conducted to determine biochemical relapse-free survival. This involves checking if there is a rise in PSA levels by 2 ng/mL or more above the lowest level reached.

    Additional evaluations will include checking for testosterone recovery, the occurrence of non-pathological fractures, cardiovascular events, erectile dysfunction, and quality of life.

Who can join the trial?

6 criteria

  • Must be over 18 years old.
  • Must have signed informed consent, which means you agree to participate after understanding the study details.
  • Must have a confirmed diagnosis of prostate adenocarcinoma, a type of prostate cancer, through a tissue sample test.
  • Must be considered suitable for a specific type of prostate treatment called ultrahypofractionated treatment. This means having an IPSS score (a measure of urinary symptoms) of less than 15 and a prostate volume of less than 90 cubic centimeters.
  • Must be a candidate for androgen deprivation therapy, a treatment to lower male hormones for managing prostate cancer.
  • Must have unfavourable intermediate risk prostate cancer, which includes having a Gleason score of 4+3, more than 50% of biopsy samples positive, or more than two intermediate risk factors.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients with medical conditions other than intermediate risk prostate cancer cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Relugolix is a medication used in this clinical trial to help treat prostate cancer. It works by lowering the levels of certain hormones in the body, which can help slow down or stop the growth of cancer cells. In this study, patients take Relugolix orally, meaning they swallow it in pill form. The goal is to see if this medication, when used alongside a specific type of radiation therapy, can effectively reduce the levels of a protein called PSA in the blood, which is an indicator of prostate cancer activity.

What is already known about the treatment

Relugolix – Relugolix is an oral medication taken by mouth, currently being studied for its effectiveness in treating intermediate risk prostate cancer. It is part of ongoing clinical trials and is gaining attention in medical literature for its potential benefits. The main therapeutic use of Relugolix is to help manage prostate cancer by reducing levels of prostate-specific antigen (PSA) in the blood. At the molecular level, Relugolix works by blocking certain hormones that stimulate cancer growth, specifically by inhibiting the action of gonadotropin-releasing hormone (GnRH) receptors. It is classified pharmacologically as a GnRH receptor antagonist.

Investigated diseases

Intermediate risk prostate cancer – This form of prostate cancer is characterized by a moderate likelihood of spreading beyond the prostate gland. It typically involves a higher prostate-specific antigen (PSA) level and a Gleason score that indicates a moderate grade of cancer cells. The disease progresses as cancer cells grow and potentially spread to nearby tissues or lymph nodes. Over time, the cancer may become more aggressive, increasing the risk of metastasis. The progression can vary significantly among individuals, with some experiencing slow growth and others facing a more rapid advancement. Monitoring PSA levels is crucial in understanding the disease's progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518388-37-00Protocol codeUltra-HEROEstimated enrolment73 patientsSponsorFondazione Radioterapia Oncologica Onlus

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