Study on the Effectiveness of Dutasteride with Goserelin Acetate and Bicalutamide in Patients with Recurrent or Metastatic Salivary Duct Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Salivary Duct Carcinoma, which affects the salivary glands. The study is investigating the effectiveness of a treatment that combines a medication called Dutasteride with a therapy known as combined androgen blockade. This therapy involves using medications that block male hormones, which can help slow the growth of certain types of cancer. The medications used in this study include Dutasteride, Zoladex, and Casodex. Zoladex is administered as an implant under the skin, while Casodex is taken orally as a tablet.

The purpose of the study is to determine how effective the combination of Dutasteride and combined androgen blockade therapy is in treating patients with recurrent or metastatic Salivary Duct Carcinoma. The study will compare the outcomes of patients receiving the combination treatment to those receiving only the combined androgen blockade therapy. Some participants will receive a placebo instead of Dutasteride to help researchers understand the treatment’s effects more clearly.

Participants in the study will receive treatment for a period of up to 12 months, with regular check-ups to monitor their health and the progress of the cancer. The study will also collect information on the overall response to the treatment, the duration of response, and any side effects experienced. The trial aims to provide valuable insights into the potential benefits of adding Dutasteride to the existing treatment regimen for this type of cancer.

1 initial visit

Upon joining the study, you will have an initial visit with the clinical trial team. During this visit, your medical history will be reviewed, and you will undergo a physical examination. Blood tests and imaging studies may be conducted to assess your current health status and the extent of your salivary duct carcinoma.

2 treatment assignment

You will be randomly assigned to one of two treatment groups. One group will receive a combination of goserelin acetate, bicalutamide, and dutasteride, while the other group will receive only goserelin acetate and bicalutamide. This process is called randomization and ensures that the study results are unbiased.

3 medication administration

If you are in the group receiving all three medications, you will receive a goserelin acetate implant (10.8 mg) as a subcutaneous injection every 12 weeks. You will also take bicalutamide tablets (50 mg) orally once a day and dutasteride capsules (0.5 mg) orally once a day.

If you are in the group receiving only goserelin acetate and bicalutamide, you will follow the same schedule for these two medications without taking dutasteride.

4 regular follow-up visits

You will have regular follow-up visits with the clinical trial team. These visits will occur at specified intervals to monitor your response to the treatment and to check for any side effects. Blood tests, imaging studies, and other assessments may be conducted during these visits.

5 quality of life assessments

Throughout the trial, you will be asked to complete questionnaires about your quality of life. These assessments help the research team understand how the treatment affects your daily life and well-being.

6 end of treatment

At the end of the treatment period, you will have a final visit with the clinical trial team. Your overall health and response to the treatment will be evaluated. You may undergo additional tests and assessments as part of this final evaluation.

Who Can Join the Study?

Must have a confirmed diagnosis of salivary duct carcinoma that cannot be cured.
Must have adequate heart function.
The disease must be AR positive, meaning there is a strong presence of androgen receptors in at least 1% of the cancer cells.
Must have a measurable disease according to specific medical guidelines.
Must be 18 years or older.
Must provide written informed consent as required by local laws.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have adequate bone marrow function, which includes having enough white blood cells, neutrophils, hemoglobin, and platelets.
Must have adequate liver function, with specific limits on liver enzymes and bilirubin levels.
Must have adequate kidney function, with specific limits on creatinine levels or a certain level of kidney filtration rate.

Who Cannot Join the Study?

Patients who are not diagnosed with Salivary Duct Carcinoma cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Smkanmhea Rccrfpu Ujgeyujdxi Mcrtcun Cojdla	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Dutasteride is a medication that is being tested in this trial to see if it can help treat salivary duct carcinoma, a type of cancer. It works by blocking certain hormones in the body that can help cancer cells grow. In this study, researchers want to find out if adding dutasteride to the usual cancer treatment can improve outcomes for patients with this type of cancer.

Combined Androgen Blockade Therapy is a standard treatment for certain types of cancer, including salivary duct carcinoma. This therapy works by reducing the levels of male hormones, which can help slow down or stop the growth of cancer cells. In this trial, combined androgen blockade therapy is used as a base treatment, and researchers are testing whether adding another medication, dutasteride, can make it more effective.

Investigated diseases:

Salivary gland cancer

Salivary Duct Carcinoma – Salivary duct carcinoma is a rare and aggressive type of cancer that originates in the ducts of the salivary glands. It typically begins as a small, painless lump in the mouth or neck area. As the disease progresses, the tumor may grow rapidly and invade surrounding tissues, leading to symptoms such as pain, difficulty swallowing, or facial nerve dysfunction. The cancer cells can spread to nearby lymph nodes and other parts of the body, including the lungs and bones. This type of carcinoma is known for its potential to recur after initial treatment. The progression of the disease can vary, with some cases remaining localized while others become more widespread.

Trial ID:

2022-500745-24-00

NCT ID:

NCT05513365

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Effectiveness of Dutasteride with Goserelin Acetate and Bicalutamide in Patients with Recurrent or Metastatic Salivary Duct Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?