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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Ruber Internacional Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Salut Sant Joan De Reus Reus Spain
Servei De Salut De Les Illes Balears Palma Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
17.03.2023

Trial locations

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.

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 ID:
2024-517666-41-00
Protocol code:
URONCOR 06-24
Trial Phase:
Therapeutic confirmatory (Phase III)

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