Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
NCT01995513
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Men with metastatic castration-resistant prostate cancer
- Progressive disease on androgen deprivation therapy
- Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
- ECOG performance score ≤ 1
- Estimated life expectancy of ≥ 12 months
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
enzalutamide for the treatment of prostate cancer
- Prior participation in a clinical trial of an investigational agent that inhibits the
androgen receptor or androgen synthesis (unless the treatment was placebo)
- History of brain metastasis, active leptomeningeal disease or seizure
- Severe cardiovascular or hepatic disease
- Pituitary or adrenal dysfunction
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- East Orange, New Jersey
- Baltimore, Maryland
- New Brunswick, New Jersey
- Durham, North Carolina
- Nagoya, Aichi
- Nagoya, Aichi
- Matsuyama, Ehime
- Iizuka, Fukuoka
- Isesaki, Gunma
- Maebashi, Gunma
- Ota, Gunma
- Hakodate, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Mito, Ibaraki
- Sagamihara, Kanagawa
- Yokohama, Kanagawa
- Yokohama, Kanagawa
- Yokosuka, Kanagawa
- Kashihara, Nara
- Kurashiki, Okayama
- Hirakata, Osaka
- Osakasayama, Osaka
- Suita, Osaka
- Kitaadachi-gun, Saitama
- Hamamatsu, Shizuoka
- Utsunomiya, Tochigi
- Bunkyo-ku, Tokyo
- Bunkyo-ku, Tokyo
- Koto-ku, Tokyo
- Nakano-ku, Tokyo
- Shinagawa-ku, Tokyo
- Shinjuku-ku, Tokyo
- Ube, Yamaguchi
- Chiba,
- Chiba,
- Fukuoka,
- Fukuoka,
- Fukuoka,
- Hiroshima,
- Kyoto,
- Nagano,
- Nagano,
- Nagasaki,
- Osaka,
- Osaka,
- Osaka,
- Saga,
- Tokushima,
- Toyama,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients | ||||||
Official Title ICMJE | A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER | ||||||
Brief Summary | The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE | Prostate Cancer | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 509 | ||||||
Original Estimated Enrollment ICMJE | 500 | ||||||
Estimated Study Completion Date ICMJE | May 31, 2024 | ||||||
Actual Primary Completion Date | November 15, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Denmark, Finland, France, Italy, Slovakia, Spain, Sweden, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01995513 | ||||||
Other Study ID Numbers ICMJE | MDV3100-10 2013-000722-54 ( EudraCT Number ) C3431013 ( Other Identifier: Alias Study Number ) PLATO, C3431013 ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE |
| ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |