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

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• enzalutamide — DRUG
  Subjects will receive enzalutamide orally once daily at the same time each day.
• abiraterone acetate — DRUG
  Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
• prednisone — DRUG
  Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
• Leuprolide acetate — DRUG
  Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Study Details

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Key Dates

Start date

Dec 22, 2016

Status verified

Mar 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

900 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: enzalutamide
  Subjects will receive enzalutamide orally once daily at the same time each day
• Experimental: enzalutamide plus abiraterone acetate and prednisone
  Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
• Experimental: Enzalutamide plus leuprolide acetate
  Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: Until End of Study (Up to 96 Months) ]

Central Contacts

• Astellas Pharma Global Development
  800-888-7704
  [email protected]

Locations (50)

Find similar trials in Anchorage, AK

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