Trial record 2 of 47 for:    astellas medivation

A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Medivation, Inc.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT02384382
First received: March 4, 2015
Last updated: February 18, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to evaluate 18F-sodium fluoride positron-emission tomography / computed tomography (18F-NaF PET/CT) imaging as a method for determining treatment response in metastatic bone lesions in patients who are receiving enzalutamide for castration-resistant prostate cancer.

Condition Intervention Phase
Prostate Carcinoma Metastatic to the Bone
Castration Resistant Prostate Cancer
Drug: Enzalutamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm Study of 18F-Sodium Fluoride PET/CT Bone Imaging in Enzalutamide-Treated Chemotherapy-Naïve Patients With Bone-Metastatic Castration-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Proportion of patients with at least one responding bone lesion (defined as a lesion with a total standardized uptake value less than that at baseline) on the third 18F-NaF PET/CT scan performed for each patient [ Time Frame: From date of treatment initiation until the date of first documented disease progression up to 2 years after treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heterogeneity of response across all bone lesions as determined by the global heterogeneity of NaF standardized uptake value [ Time Frame: From date of treatment initiation until the time point of the primary endpoint determination for each patient up to 2 years after treatment initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
  • Presence of bone metastatic disease as assessed by at least two lesions on whole body metastable technetium-methylene diphosphonate (99mTc-MDP) bone scintigraphy;
  • Throughout the study, ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) analogue or prior bilateral orchiectomy (medical or surgical castration);
  • Testosterone ≤ 1.73 nmol/L (≤ 50 ng/dL) at screening;
  • Progressive disease on androgen deprivation therapy at screening defined as a minimum of two sequentially rising prostate-specific antigen (PSA) values (PSA1 < PSA2 < PSA3);
  • The screening PSA (PSA3) must be ≥ 2 μg/L (≥ 2 ng/mL).

Exclusion Criteria:

  • Prior enzalutamide, abiraterone acetate, aminoglutethimide, ketoconazole, radium Ra 223 dichloride or other bone-targeting radionuclides, or cytotoxic chemotherapy in the CRPC setting for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
  • Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than LHRH analogue therapy) within 4 weeks before enrollment;
  • Initiation of new treatment with denosumab, bisphosphonates, or systemic corticosteroids for treatment of prostate cancer within 4 weeks before enrollment;
  • Use of an investigational agent within 4 weeks before the screening visit;
  • Radiation therapy to bone within 4 weeks before enrollment;
  • Use of opiate analgesics for prostate cancer pain within 4 weeks before enrollment;
  • Screening 99mTc-MDP bone scintigraphy showing a superscan;
  • Visceral (eg, lung, liver) metastatic disease. Adenopathy is allowed;
  • Current or previously treated brain metastasis or active leptomeningeal disease;
  • History of seizure any time in the past for any reason or any condition that may predispose to seizures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02384382

Contacts
Contact: Medivation Clinical Operations +1 (415) 543-3470
Contact: Medivation Clinical Trial Disclosure TrialDisclosure@Medivation.com

Locations
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New Jersey
Recruiting
New Brunswick, New Jersey, United States, 08903
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Director: Medical Director Medivation, Inc.
  More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT02384382     History of Changes
Other Study ID Numbers: MDV3100-18 
Study First Received: March 4, 2015
Last Updated: February 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Cancer of the Prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 25, 2016