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Spots Global Cancer Trial Database for Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

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Trial Identification

Brief Title: Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Official Title: A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Study ID: NCT04666129

Study Description

Brief Summary: This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

Detailed Description: This is a three-part, open-label, parallel-cohort study to assess the safety and tolerability of relugolix as the ADT component in combination treatment with abiraterone acetate plus a corticosteroid in patients with mCSPC or mCRPC (Part 1), apalutamide in patients with mCSPC or nmCRPC (Part 2), or docetaxel with or without prednisone in patients with mCSPC or mCRPC (Part 3). The study will consist of a 45-day screening period followed by a 12-week treatment period with one of the three combination treatments (Parts 1, 2, or 3). All participants are required to be currently or previously treated with a GnRH receptor antagonist (analog), leuprolide acetate or triptorelin, or a GnRH receptor antagonist, degarelix or relugolix, in combination with either abiraterone plus prednisone (Part 1), apalutamide (Part 2), or docetaxel (Part 3). The study consists of a 12-week primary study treatment period in which safety and tolerability, including assessment of vital sign measurements, ECGs, clinical laboratory tests and reporting of adverse events every 2 to 4 weeks, followed by a 40-week safety extension treatment period during which adverse events and changes to concomitant medications will be reported. The total treatment duration is 52 weeks.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Urological Associates of Southern Arizona, P.C., Tucson, Arizona, United States

Arkansas Urology, Little Rock, Arkansas, United States

Colorodo Clinical Research, Lakewood, Colorado, United States

Chesapeake Urology Research Associates, Baltimore, Maryland, United States

University of Massachusetts Medical School, Worcester, Massachusetts, United States

New Jersey Urology, Saddle Brook, New Jersey, United States

Clinical Research Alliance, Inc., Westbury, New York, United States

Alliance Urology, Greensboro, North Carolina, United States

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

Helios Clinical Research, LLC., Middleburg Heights, Ohio, United States

Center for Advanced Urology, LLP d/b/a: MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States

Keystone Urology Specialists, Lancaster, Pennsylvania, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States

Urology Associates, P.C., Nashville, Tennessee, United States

UT Southwestern Medical Center, Dallas, Texas, United States

Urology San Antonio, San Antonio, Texas, United States

Contact Details

Name: Mike Ufer

Affiliation: Sumitomo Pharma America, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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