A Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

JRCT ID: jRCT2031220674

Registered date:02/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 24/05/2023
• Target sample size: 900
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Canada,Japan,Chile,Japan,Czechia,Japan,Denmark,Japan,Finland,Japan,France,Japan,Georgia,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Moldova,Japan,New Zealand,Japan,Poland,Japan,Russia,Japan,Slovakia,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,United Kingdom,Japan,Hong Kong,Japan
• Study type: Interventional

Intervention(s)

Enzalutamide: Subjects will receive enzalutamide orally once daily at the same time each day.
Enzalutamide plus abiraterone acetate and prednisone: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) may receive orally abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily.
Due to transition from study 9785-CL-0335 in Japan, concomitant use of abiraterone acetate and prednisone will not be conducted.

Outcome(s)

• Primary Outcome: Adverse events (AEs)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation / Pfizer and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
2. Subject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
3. Subject is able to swallow enzalutamide capsules and comply with study requirements.
4. Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
5. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
6. Subject agrees not to participate in another interventional study while on treatment.

Exclude criteria

1. Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
2. Subject requires treatment with or plans to use either of the following:
o New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
o Investigational therapy other than enzalutamide.
3. Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
4. Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Related Information

• Primary Sponsor: Haas Gabriel
• Secondary Sponsor: Pfizer Inc.
• Secondary ID(s): NCT02960022