A phase 2 study to evaluate the effects of ASP5541 in participants with prostate cancer, Trial ID 5541-CL-0201

Trial purpose

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitor inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone/prednisolone to manage any medical problems from the hormone therapy.

ASP5541 is a different form of AA. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone/prednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to AA.

Additional Study Details

Phase

Phase 2

Product

ASP5541

Prednisone

Prednisolone

abiraterone acetate

Type

Interventional

Masking

None (Open Label)

Enrollment number

218

Show Additional Study Details

Who May Participate

Adult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are:

Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow.
Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low.

What to expect

In this study there will be 3 treatment groups:

In Group 1, men with mCRPC who haven’t previously been treated with an ARPI will either be given ASP5541 and prednisone/prednisolone or AA and prednisone/prednisolone.
In Group 2, men with mHSPC who haven’t previously been treated with an ARPI will either be given ASP5541 by itself or be given AA with prednisone/prednisolone.
In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an ARPI will be given ASP5541 with prednisone.

ASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone/prednisolone twice daily and men with mHSPC will take prednisone/prednisolone once daily. AA will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as ADT.

The men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.

Length of study treatment

Approximately 40 months

Number of study visits

Approximately 20

Study summary

The main aims (primary objectives) of this trial are:

To check how well ASP5541 with prednisone/prednisolone works compared to AA with prednisone/prednisolone in men with advanced prostate cancer who haven’t previously been treated with an ARPI.
To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven’t previously been treated with an ARPI.
To check how well ASP5541 given by itself works compared to AA with prednisone/prednisolone in men with advanced prostate cancer that haven’t previously been treated with an ARPI.
To check the safety of ASP5541 with prednisone/prednisolone in Japanese men with advanced prostate cancer

Other aims (secondary objectives) of this trial are:

Further checks on how well ASP5541 works with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone.
To check the safety of ASP5541 given with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone
To check how ASP5541 given with and without prednisone/ prednisolone acts upon the body (pharmacodynamics) compared to AA given with prednisone/prednisolone
To check the pain levels after treatment with ASP5541 given with and without prednisone/prednisolone compared to AA given with prednisone/prednisolone

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A phase 2 study to evaluate the effects of ASP5541 in participants with prostate cancer? Contact us by filling out your information to the right and we’ll respond to you.

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Locations

Recruiting

JP81002

Koto-ku, Tokyo, Japan

Recruiting

Carolina Urologic Research Center

Myrtle Beach, SC, United States, 29572

Frequently Asked Questions

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A phase 2 study to evaluate the effects of ASP5541 in participants with prostate cancer