Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01547299
First received: February 27, 2012
Last updated: February 7, 2014
Last verified: February 2014

February 27, 2012
February 7, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
Pathological Complete Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the pathological complete response rate following triplet therapy (MDV3100 in combination with leuprolide and dutasteride) and MDV3100 alone when administered as neoadjuvant therapy for 6 months prior to prostatectomy in patients with localized prostate cancer
Same as current
Complete list of historical versions of study NCT01547299 on ClinicalTrials.gov Archive Site
  • PSA [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    To determine the effects on prostate-specific antigen (PSA) (including median nadir value, percentage of patients achieving PSA < 0.2 ng/mL, the proportion of patients achieving 50% and 90% decrease in PSA, and time to PSA nadir) for triplet therapy and MDV3100 alone
  • Determine the rate of positive surgical margins [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the rate of positive surgical margins, extracapsular extension, positive seminal vesicles and lymph nodes at the time of prostatectomy for triplet therapy and MDV3100 alone.
  • Pharmacodynamics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the effects of triplet therapy and MDV3100 alone on selected pharmacodynamic markers on prostatectomy specimens including apoptosis, mitotic index, androgen receptor signaling, and others.
  • Determine effects on testosterone and dihydrotestosterone (DHT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To determine the effects on testosterone and dihydrotestosterone (DHT) (including median values of testosterone and DHT during and at completion of therapy) for triplet therapy and MDV3100 alone
  • Assess the safety and tolerability of triplet therapy and MDV3100 alone [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of triplet therapy and MDV3100 alone in the neoadjuvant setting. Safety and tolerability will be documented throughout the study by assessment of adverse events, vital signs, electrocardiograms (ECGs), and laboratory assessments
Same as current
Not Provided
Not Provided
 
Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

The purpose of this study is to determine if MDV3100 is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: MDV3100
    MDV3100 160 mg, orally, once daily
  • Drug: MDV3100 + Leuprolide + Dutasteride
    MDV3100 160 mg, orally, once daily in combination with leuprolide 22.5 mg, IM, Q 3 Months and dutasteride, 0.5 mg, PO, QD
  • Experimental: MDV3100
    MDV3100 alone
    Intervention: Drug: MDV3100
  • Experimental: MDV3100 + Leuprolide + Dutasteride
    MDV3100 in combination with leuprolide and dutasteride
    Intervention: Drug: MDV3100 + Leuprolide + Dutasteride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing to provide informed consent
  • 18 years of age or older
  • Histologically confirmed adenocarcinoma of the prostate
  • Must be a candidate for radical prostatectomy and considered surgically resectable

Exclusion Criteria:

  • Stage T4 prostate cancer by clinical or radiologic evaluation
  • Treatment with an investigational agent within 4 weeks prior to randomization
  • Received therapy for for other neoplastic disorders within 5 years
  • Hypogonadism or severe androgen deficiency
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01547299
MDV3100-07
No
Medivation, Inc.
Medivation, Inc.
Astellas Pharma Inc
Not Provided
Medivation, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP