Study on Estradiol and Exercise to Reduce Side Effects of Androgen Deprivation Therapy in Prostate Cancer Patients

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What is this study about?

This clinical trial is focused on studying the effects of treatments for prostate cancer, a common cancer in men. The study will use a treatment called transdermal estradiol, which is a form of estrogen applied to the skin as a gel, and leuprorelin, a medication given by injection. The purpose of the study is to explore how these treatments, along with exercise, can help reduce the side effects of another treatment called androgen deprivation therapy (ADT), which is often used in combination with radiation therapy for prostate cancer.

Participants in the study will receive either the estradiol gel or a placebo, and some will also take part in a six-month exercise program. The study will last for up to one year, during which the effects of the treatments on sexual function, muscle strength, body composition, and overall quality of life will be monitored. The study aims to determine if the estradiol gel can help improve sexual dysfunction and other side effects caused by ADT.

Throughout the study, the safety and tolerability of the treatments will be closely observed. The research will also assess how the combination of estradiol and exercise impacts various health markers, such as muscle and inflammatory biomarkers, which are substances in the blood that can indicate changes in health. The ultimate goal is to find ways to improve the quality of life for men undergoing treatment for prostate cancer.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Consent will be obtained to ensure understanding and willingness to participate.

2 initial assessment

Participants will undergo an initial assessment to evaluate their health status. This includes checking eligibility criteria such as age, body mass index, and performance status.

3 treatment initiation

Participants will begin treatment with transdermal estradiol and leuprorelin acetate. Transdermal estradiol is applied as a gel on the skin, while leuprorelin acetate is administered via injection.

The transdermal estradiol gel is applied daily, and the leuprorelin acetate injection is given as per the schedule provided by the study team.

4 exercise program

Participants may be assigned to a 6-month resistance exercise program. This program aims to improve muscle strength and overall physical health during the treatment period.

5 regular monitoring

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. This includes assessing muscle strength, body composition, and quality of life.

Blood tests may be conducted to evaluate biomarkers related to health and muscle function.

6 end of treatment

After one year, the treatment phase will conclude. Participants will undergo a final assessment to evaluate the overall impact of the treatment on their health and well-being.

7 follow-up

Participants may be contacted for follow-up assessments to gather long-term data on the effects of the treatment.

Who Can Join the Study?

Men with localized prostate cancer starting radiotherapy with adjuvant ADT for at least one year.
- Radiotherapy: A treatment using radiation, often to kill cancer cells.
- Adjuvant ADT: Additional hormone therapy used to lower male hormones that can promote cancer growth.
Adults aged over 18 years.
Have a sufficient performance status of ECOG 0-1.
- Performance status: A measure of how well a person can perform ordinary tasks and carry out daily activities.
- ECOG 0-1: Indicates that the person is fully active or has some symptoms but can still carry out light work.
Willingness to participate and have signed a consent form.
Body mass index (BMI) between 18.5 and 30.0.
- Body mass index (BMI): A measure of body fat based on height and weight.

Who Cannot Join the Study?

Patients who do not have prostate cancer cannot participate.
Only male patients are eligible to participate.
Patients who are not within the specified age range cannot participate. (The specific age range is not provided here.)
Patients who are part of a vulnerable population cannot participate. (This typically refers to groups who may need special protection, such as children or those unable to give consent.)

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Tampere University Hospital	Tampere	Finland
Central Finland Hospital District Central Finland Hospital Nova	Jyvaskyla	Finland
University Of Jyvaskyla	Jyvaskyla	Finland
Virgajbhhvhbqnzl hmnoshshudhrxes	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Estradiol is a form of estrogen, which is a hormone that plays a key role in the female reproductive system. In this trial, estradiol is used in a patch form that is applied to the skin. The purpose of using estradiol in this study is to help reduce some of the negative side effects that men experience when they undergo androgen deprivation therapy (ADT) for prostate cancer. ADT is a treatment that lowers testosterone levels, which can lead to issues like sexual dysfunction. Estradiol may help improve these symptoms by providing some hormonal balance.

Investigated diseases:

Prostate cancer

Prostate cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in males that produces seminal fluid. As the cancer progresses, it may spread to nearby tissues or other parts of the body. Early stages often have no symptoms, but as it advances, it can cause urinary problems, pelvic discomfort, or bone pain. The growth rate of prostate cancer can vary, with some types growing slowly and others more aggressively. The progression can lead to complications if the cancer spreads beyond the prostate gland.

Trial ID:

2023-504704-28-00

Protocol code:

ESTRACISE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Estradiol and Exercise to Reduce Side Effects of Androgen Deprivation Therapy in Prostate Cancer Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?