A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07005154
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP5541 — DRUG
    Intramuscular Injection
  • Prednisone — DRUG
    Oral
  • Prednisolone — DRUG
    Oral
  • abiraterone acetate — DRUG
    Oral
  • Adrenocorticotropic hormone — DRUG
    Intramuscular or intravenous injection

Study Details

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 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 abiraterone acetate. 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 abiraterone acetate. The main aims of the study 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. 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. In this study there will be 3 treatment groups: * In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone/prednisolone or be given abiraterone acetate and prednisone/prednisolone. * In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone/prednisolone. * In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone/prednisolone. 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. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy. The men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. 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.

Key Dates

Start date
Jun 19, 2025
Status verified
Apr 2026
Primary completion
May 31, 2032
Completion
May 31, 2032

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (mCRPC) Group A
    Participants will receive ASP5541 every 12 weeks + prednisone/prednisolone twice daily
  • Active Comparator: Cohort 1 (mCRPC) Group B
    Participants will receive abiraterone acetate once daily + prednisone/prednisolone twice daily
  • Experimental: Cohort 2 (mHSPC) Group A (Safety Run In)
    Participants will receive ASP5541 every 12 weeks
  • Experimental: Cohort 2 (mHSPC) Group B
    Participants will receive ASP5541 every 12 weeks
  • Active Comparator: Cohort 2 (mHSPC) Group C
    Participants will receive abiraterone acetate once daily + prednisone/prednisolone once daily
  • Experimental: Cohort 3 (mCRPC or mHSPC) Japanese Participants Only
    Participants will receive ASP5541 every 12 weeks + prednisone/prednisolone twice daily (for mCRPC) or prednisone/prednisolone once daily (for mHSPC)

Primary Outcome Measure

Proportion of androgen receptor pathway inhibitor (ARPI) -naïve metastatic castration-resistant prostate cancer (mCRPC) participants with Prostate Specific Antigen (PSA) decline ≥ 90% (Cohort 1) [ Time Frame: Up to 37 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama35805-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Associated Urological SpecialistsChicago RidgeIllinois60415-
Ochsner Health - Ochsner Medical Center - New OrleansNew OrleansLouisiana70121-
New Mexico Oncology Hematology ConsultantsAlbuquerqueNew Mexico87109-
Solaris Health - The Urology GroupCincinnatiOhio45212-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Tennessee Oncology NashvilleNashvilleTennessee37203-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-07-
UW Health Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Huntsville, AL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Clearview Cancer Institute· Huntsville, ALH. Lee Moffitt Cancer Center· Tampa, FLAssociated Urological Specialists· Chicago Ridge, ILOchsner Health - Ochsner Medical Center - New Orleans· New Orleans, LANew Mexico Oncology Hematology Consultants· Albuquerque, NMSolaris Health - The Urology Group· Cincinnati, OH

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