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Study on Stereotactic Body Radiation Therapy with or without Durvalumab for Patients with Oligometastatic Hormone-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as oligometastatic hormone-sensitive prostate cancer. This condition occurs when prostate cancer has spread to a few other parts of the body but still responds to hormone therapy. The study is exploring the effects of a treatment called Durvalumab, also known by its code name MEDI4736, in combination with a precise form of radiation therapy called Stereotactic Body Radiation Therapy (SBRT). Durvalumab is a medication that helps the immune system fight cancer cells.

The purpose of the study is to see if combining SBRT with Durvalumab can help patients live longer without the cancer getting worse. Participants in the study will be randomly assigned to receive either SBRT alone or SBRT with Durvalumab. The study will last for up to two years, during which time participants will receive treatment and attend regular follow-up visits to monitor their health and the progression of the cancer.

Throughout the study, researchers will track various outcomes, such as how long it takes for the cancer to progress, the overall survival of participants, and any side effects experienced. The study aims to provide valuable information on whether the combination of SBRT and Durvalumab can offer better outcomes for patients with this type of prostate cancer.

1 joining the study

Upon joining the study, the patient provides written informed consent. This is a necessary step before any study-related procedures can begin.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility. This includes verifying a diagnosis of oligometastatic hormone-sensitive prostate cancer and ensuring the patient meets specific health criteria.

3 randomization

The patient is randomly assigned to one of two groups: one receiving stereotactic body radiation therapy (SBRT) alone, and the other receiving SBRT combined with Durvalumab.

4 treatment phase

For patients receiving Durvalumab, the medication is administered as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

The treatment phase includes regular administration of the assigned therapy and monitoring for any side effects or complications.

5 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment are closely monitored. This includes regular visits and examinations.

The study aims to assess progression-free survival over two years, with specific criteria for progression being monitored.

6 end of study participation

The study is estimated to conclude by December 29, 2026. At the end of the study, the patient’s overall health and any long-term effects of the treatment are evaluated.

Who Can Join the Study?

  • The patient must provide written informed consent before any study-related procedures are done.
  • The patient must weigh more than 30 kilograms.
  • The patient should have a life expectancy of more than 24 months.
  • The patient must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations.
  • The patient must have social insurance.
  • The patient must be 18 years or older at the time of joining the study.
  • The patient must have a confirmed diagnosis of prostate cancer through a tissue sample test.
  • The patient must have a rising PSA level, which is a blood test used to monitor prostate cancer, after treatment aimed at curing the cancer, such as surgery or radiation.
  • The patient can have a maximum of 5 bone or lymph node metastases (cancer spread) detected by specific scans, with size limits for these metastases.
  • The patient must have a WHO performance state of 0-1, which means they are fully active or have some symptoms but do not need bed rest.
  • The primary tumor must be controlled. If the PSA level is above 0.2 ng/ml after surgery, further scans must show no local cancer return. If suspicious areas are found, a biopsy must confirm local recurrence, and the patient should be considered for additional surgery if no distant spread is found.
  • If the patient has previously received ADT (Androgen Deprivation Therapy), at least 12 months must have passed since the last treatment, and testosterone levels must be above a certain level before joining the study.
  • The patient must have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function.

Who Cannot Join the Study?

  • Patients who do not have oligometastatic hormone sensitive prostate cancer cannot participate. This means the cancer has spread to a few other places in the body but still responds to hormone treatment.
  • Females cannot participate in this study.
  • Individuals who are considered part of a vulnerable population are not eligible. This generally refers to people who might have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
Clinique Pasteur Toulouse France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Clinique Pasteur Lanroze Brest France
Groupe Hospitalier Bretagne Sud Lorient France
Institut De Cancerologie De Bourgogne Dijon France
Centre Hospitalier Lyon Sud Pierre Benite France
Institut Sainte Catherine Avignon France
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
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Clzooh Arbtjyp dj Clsfqzrelyxz Mougins France
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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
France France
Not recruiting
21.03.2019

Trial locations

Investigated drugs:

Stereotactic Body Radiation Therapy (SBRT) is a type of radiation therapy that delivers high doses of radiation to a targeted area of the body. It is used in this trial to treat patients with oligometastatic recurrent hormone-sensitive prostate cancer. The goal is to precisely target cancer cells while minimizing damage to surrounding healthy tissue.

Durvalumab (MEDI4736) is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this trial, it is being tested in combination with SBRT to see if it improves outcomes for patients with oligometastatic recurrent hormone-sensitive prostate cancer.

Oligometastatic Hormone-Sensitive Prostate Cancer – This is a form of prostate cancer where the disease has spread to a limited number of sites outside the prostate gland but remains sensitive to hormone therapy. The cancer cells rely on male hormones, like testosterone, to grow. In this stage, the cancer is not widespread, and the number of metastatic sites is typically small. The progression of the disease can be monitored through various markers, including PSA levels, which indicate biochemical progression. Over time, the cancer may progress locally or to distant sites, and the response to hormone therapy may change.

Trial ID:
2024-513207-13-00
Protocol code:
POSTCARD – GETUG-P13
NCT ID:
NCT03795207
Trial Phase:
Therapeutic exploratory (Phase II)

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