Study on the Safety and Effects of AZD5305 with Hormonal Agents for Patients with Metastatic Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a condition known as metastatic prostate cancer, which is a type of cancer that has spread from the prostate to other parts of the body. The study is testing a new treatment called AZD5305, also known as Saruparib, in combination with several existing medications used to treat prostate cancer. These medications include enzalutamide (marketed as Xtandi), abiraterone acetate (marketed as ZYTIGA), darolutamide (marketed as NUBEQA), and apalutamide (marketed as Erleada). The purpose of the study is to assess the safety and tolerability of AZD5305 when used alongside these hormonal agents.

Participants in the study will receive AZD5305 in combination with one of the hormonal agents mentioned above. The study will monitor participants for any side effects or adverse reactions to the treatment. The trial will also look at how the body processes AZD5305 and the hormonal agents, which is known as pharmacokinetics, and how the drugs affect the body, known as pharmacodynamics. The study aims to gather preliminary information on how effective the combination treatments are in managing metastatic prostate cancer.

The trial is designed to be open-label, meaning both the researchers and participants will know which treatments are being administered. The study will take place over several phases, starting with an initial assessment of safety and tolerability, followed by further evaluation of the treatment’s effects. Participants will be closely monitored throughout the study to ensure their well-being and to collect data on the treatment’s impact on their cancer. The study is expected to continue until December 2025.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of metastatic prostate cancer, and other health conditions.

Participants must be at least 18 years old and have a confirmed diagnosis of metastatic prostate cancer.

2 treatment initiation

The study involves the administration of a new drug, AZD5305, in combination with one of the following hormonal agents: enzalutamide, abiraterone acetate, darolutamide, or apalutamide.

These medications are taken orally in the form of tablets or capsules.

3 medication details

The specific dosage and frequency of each medication are determined by the study protocol and may vary depending on the combination used.

Participants will be informed of their specific medication schedule at the start of the treatment.

4 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the safety and tolerability of the treatment.

This includes physical examinations, laboratory tests, and assessments of vital signs.

5 evaluation of treatment effects

The study evaluates the effects of the treatment on the cancer, including changes in tumor size and prostate-specific antigen (PSA) levels.

Participants may also undergo imaging tests to assess the progression of the cancer.

6 completion of the study

The study is expected to continue until December 2025, with individual participation duration varying based on treatment response and other factors.

Upon completion, participants may receive follow-up care as determined by their healthcare provider.

Who Can Join the Study?

Must be at least 18 years old at the time of screening.
For Part A: Must have either Metastatic Castration-Resistant Prostate Cancer (mCRPC) or Metastatic Castration-Sensitive Prostate Cancer (mCSPC). “Metastatic” means the cancer has spread to other parts of the body. “Castration-resistant” means the cancer continues to grow even when the amount of male hormones in the body is reduced to very low levels. “Castration-sensitive” means the cancer still responds to treatments that lower male hormones.
For Part B: Must have mCSPC, which can be either newly diagnosed or a recurrence.
Must have a confirmed diagnosis of metastatic prostate cancer through a tissue sample.
Must be a suitable candidate for treatment with one of the following medications: enzalutamide, abiraterone acetate, darolutamide, or apalutamide, with current evidence of metastatic prostate cancer.
Must be either surgically or medically castrated, meaning the levels of male hormones are reduced to very low levels.
Must have adequate function of organs and bone marrow, which are important for overall health and recovery.
Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, which means the patient is fully active or has some symptoms but does not require bed rest. There should be no worsening of this status in the last 2 weeks.
Must have a life expectancy of at least 16 weeks.
Non-sterilized male patients who are sexually active with a female partner who can become pregnant must use a condom with spermicide from the start of the study until about 6 months after the last dose of the study treatment.
For patients in specific tumor study groups: Must have at least one tumor that can be biopsied twice for study purposes. A biopsy is a procedure where a small sample of tissue is taken for examination.

Who Cannot Join the Study?

Patients who are not male cannot participate.
Patients who do not have metastatic prostate cancer cannot participate. Metastatic means that the cancer has spread to other parts of the body.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	08.02.2024

Trial locations

Investigated drugs:

AZD5305 is an investigational medication being studied for its potential to treat metastatic prostate cancer. It is being tested to see how safe and tolerable it is when used in combination with other treatments. Researchers are also looking at how the body processes this medication and its preliminary effectiveness in treating cancer.

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this trial, it is being used in combination with AZD5305 to see if the combination is more effective.

Abiraterone Acetate is another treatment for prostate cancer. It works by decreasing the production of male hormones in the body, which can help slow the growth of cancer cells. This trial is testing its use alongside AZD5305 to evaluate the safety and potential benefits of the combination.

Darolutamide is a medication that helps treat prostate cancer by blocking the action of male hormones. It is being combined with AZD5305 in this study to determine if the combination is safe and effective for patients with metastatic prostate cancer.

Apalutamide is used to treat prostate cancer by inhibiting the effects of male hormones that can fuel cancer growth. The trial is investigating the effects of using apalutamide together with AZD5305 to assess the safety and potential improvement in treatment outcomes.

Investigated diseases:

Prostate cancer metastatic

Metastatic Prostate Cancer – This is a type of cancer that begins in the prostate gland and spreads to other parts of the body, such as bones, lymph nodes, or other organs. The disease progresses as cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other areas. Symptoms may include difficulty urinating, bone pain, and fatigue, depending on where the cancer has spread. Over time, the cancer can affect the function of the organs it has spread to, leading to more complex symptoms. The progression of the disease can vary greatly among individuals, with some experiencing rapid spread and others having a slower progression.

Trial ID:

2023-508536-64-00

Protocol code:

D9720C00003

NCT ID:

NCT05367440

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of AZD5305 with Hormonal Agents for Patients with Metastatic Prostate Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?