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NCT07005154 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Astellas Pharma Global Development.

Recruiting
Registry status
Phase 2
Development phase
218
Enrollment target
12
Study locations

NCT07005154 is a Phase 2 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 218 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (64% lower). The trial reports 12 study locations across 8 states.

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The verdict

NCT07005154, a Phase 2 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Astellas Pharma Global Development.

RECRUITING
Registry status
Phase 2
Development phase
218 participants
Enrollment target
12
Study locations

Study Summary

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 co

Conditions Studied

Prostate Cancer Metastatic Castration-Resistant Prostate Cancer Metastatic Hormone-sensitive Prostate Cancer

Interventions

  • DRUG Prednisone
  • DRUG abiraterone acetate
  • DRUG Prednisolone
  • DRUG ASP5541
  • DRUG Adrenocorticotropic hormone

Study Locations (12)

Other

  • Harasanshin Hospital - Fukuoka
  • Osaka International Cancer Institute - Osaka
  • PanOncology Trials - San Juan
  • KR82008 - Gwangju

Tokyo

  • Nippon Medical School Hospital - Bunkyo-ku
  • The Cancer Institute Hospital of JFCR - Koto-ku

Florida

  • H. Lee Moffitt Cancer Center - Tampa

New Mexico

  • New Mexico Oncology Hematology Consultants - Albuquerque

South Carolina

  • Carolina Urologic Research Center - Myrtle Beach

Baden-Wurttemberg

  • DE49004 - Nürtingen

Chiba

  • National Cancer Center Hospital East - Kashiwa

Shizuoka

  • Shizuoka Cancer Center - Sunto-gun

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2025-06-19
Est. Completion 2032-05-31
Phase Phase 2

Sponsor

Astellas Pharma Global Development

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07005154

The ClinicalTrials.gov registry entry for NCT07005154 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (64% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Prednisone is the first listed.

NCT07005154 reports 12 study locations spanning 8 distinct geographic areas - top geographies include Other, Tokyo, Florida.

Frequently Asked Questions

What is clinical trial NCT07005154 about?

NCT07005154 is a clinical study titled "A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer". 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 ...

What is the current status of trial NCT07005154?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2025-06-19. Estimated completion is 2032-05-31.

What conditions does trial NCT07005154 study?

This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer.

What interventions are being tested in trial NCT07005154?

The interventions under investigation include: Prednisone (DRUG), abiraterone acetate (DRUG), Prednisolone (DRUG), ASP5541 (DRUG), Adrenocorticotropic hormone (DRUG).

Who is sponsoring clinical trial NCT07005154?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07005154 being conducted?

This trial has 12 study locations across Florida, New Mexico, South Carolina, Baden-Wurttemberg, Chiba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.