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Comparison of Short vs Long-term Hormone Therapy with Goserelin, Leuprorelin, or Triptorelin Combined with Radiation for Prostate Cancer Patients After Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with prostate cancer who have experienced a return of the disease after surgery (known as biochemical recurrence). The study aims to compare two different lengths of treatment using androgen deprivation therapy (a treatment that lowers male hormone levels) combined with salvage radiotherapy (radiation treatment given after surgery).

The study will test three different medications that work to reduce male hormones: Decapeptyl (containing triptorelin), Zoladex (containing goserelin), and Eligard (containing leuprorelin). Some patients will also receive bicalutamide tablets. The medications will be given either as injections under the skin or as tablets to take by mouth. The study compares a short-term treatment lasting 6 months with a longer treatment lasting 24 months.

The main purpose of this research is to determine if using hormone-lowering treatment for a longer time (24 months) leads to better results than shorter treatment (6 months) in preventing the cancer from spreading to other parts of the body. The effectiveness of the treatment will be measured over a 5-year period after starting the therapy.

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

    You will receive salvage radiotherapy treatment for prostate cancer that has returned after surgery.

    You will be randomly assigned to one of two treatment groups: either 6-month or 24-month hormone therapy.

    Your testosterone level must be above 150 ng/dL to start the treatment.

  2. Step 2

    Hormone therapy administration

    You will receive one of these hormone treatments:

    Option 1: Zoladex 3.6 mg implant given by injection under the skin

    Option 2: Eligard 45 mg injection solution every six months

    Option 3: Decapeptyl 22.5 mg long-acting injection

    You may also receive Bicalutamide 50 mg tablets taken by mouth

  3. Step 3

    Treatment duration

    If assigned to the short-term group: hormone therapy will last for 6 months

    If assigned to the long-term group: hormone therapy will last for 24 months

    Regular PSA blood tests will be performed to monitor your response to treatment

  4. Step 4

    Follow-up period

    Your health status will be monitored for up to 5 years

    Regular checks will be performed to detect if the cancer has spread

    The study will continue until March 2026

Who can join the trial?

10 criteria

  • Must be a male patient with prostate cancer confirmed through tissue examination (histology) who has previously undergone surgical removal of the prostate (radical prostatectomy)
  • Must have a rising PSA level (a blood test that measures a protein specific to prostate) of at least 0.2 ng/mL, confirmed by a second higher test result at least 2 weeks later
  • For patients with more aggressive cancer features (Gleason score 8-10, advanced tumor stage, or positive surgical margins), a PSA level of at least 0.15 ng/mL is acceptable
  • If PSA is above 0.4 ng/mL, imaging tests must be done to check for cancer spread
  • Must have intermediate or high-risk disease according to specific medical criteria
  • Must have a normal testosterone level (above 150 ng/dL) in blood tests
  • Must be able to perform daily activities independently or with minimal assistance (ECOG score 0-1)
  • Must have a life expectancy of more than 5 years
  • Must be willing and able to provide written informed consent
  • Must be an adult male

Who cannot join the trial?

10 criteria

  • Patients who are not male (females cannot participate)
  • Patients under 18 years of age or over 65 years old
  • Patients who do not have a confirmed diagnosis of prostate cancer
  • Patients who have not previously received radiotherapy treatment
  • Patients who are currently receiving other forms of hormone therapy (ADT - Androgen Deprivation Therapy)
  • Patients who have distant metastases (cancer that has spread to other parts of the body)
  • Patients who are participating in other clinical trials
  • Patients who belong to vulnerable populations (such as those unable to provide informed consent)
  • Patients with severe medical conditions that could interfere with the study treatment
  • Patients who have had previous pelvic radiation therapy
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Investigated drugs

  • Androgen Deprivation Therapy (ADT)

    is a hormonal treatment that reduces testosterone levels in the body. This therapy is used to slow down or stop the growth of prostate cancer cells, as these cells typically need testosterone to grow. The treatment works by either blocking the body's ability to produce testosterone or preventing testosterone from affecting cancer cells.

  • Salvage Radiotherapy

    is a treatment that uses high-energy radiation beams to target and destroy cancer cells. It is called "salvage" therapy because it is used after initial prostate cancer treatment (in this case, prostatectomy) when there are signs that the cancer might be returning. The radiation is precisely directed at the area where the prostate used to be and any surrounding areas where cancer cells might be present.

What is already known about the treatment

  • Androgen Deprivation Therapy (ADT)

    A hormone therapy administered through injections or oral medications that reduces testosterone levels in the body to treat prostate cancer. This treatment works by either blocking the body's ability to produce androgens (male hormones) or preventing these hormones from reaching cancer cells, effectively slowing or stopping prostate cancer growth. ADT is commonly used in combination with radiation therapy as a standard treatment approach for prostate cancer, particularly in cases where the cancer has recurred after initial prostatectomy. It belongs to the class of hormonal therapies and represents one of the primary systemic treatments for prostate cancer, though it may cause side effects such as hot flashes, decreased libido, and potential bone density loss.

  • Salvage Radiotherapy

    A targeted form of radiation treatment delivered externally to the prostate bed area where cancer has recurred after previous prostate surgery. This therapy uses high-energy X-ray beams to damage cancer cells' DNA, preventing them from growing and dividing, and is typically administered in multiple sessions over several weeks at a radiation oncology facility. Salvage radiotherapy is specifically used for patients who show signs of cancer recurrence after prostatectomy, as indicated by rising PSA levels, and can be combined with hormone therapy to improve treatment outcomes. It belongs to the category of local therapies and represents a crucial second-line treatment option for recurrent prostate cancer.

Investigated diseases

Prostate Cancer - A disease that develops in the prostate gland, which is part of the male reproductive system. It typically begins when prostate cells start to grow uncontrollably and form tumors. The condition usually develops slowly over many years, starting in the outer parts of the prostate and gradually spreading within the gland. As the disease progresses, cancer cells can spread to nearby tissues and potentially to other parts of the body. This type of cancer is most common in older men, with the risk increasing with age. The condition often develops without noticeable early symptoms, though it may eventually affect urinary function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517666-41-00Protocol codeURONCOR 06-24Estimated enrolment534 patientsSponsorInstituto De Investigacion En Oncología Radioterapica FEOR

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