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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01547299
First received: February 27, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Prostate Cancer
 Drug: MDV3100
Drug: MDV3100 + Leuprolide + Dutasteride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100
MDV3100 alone
 Drug: MDV3100
MDV3100 160 mg, orally, once daily
Experimental: MDV3100 + Leuprolide + Dutasteride
MDV3100 in combination with leuprolide and dutasteride
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547299

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Washington
Seattle, Washington, United States, 98195
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01547299     History of Changes
Other Study ID Numbers: MDV3100-07
Study First Received: February 27, 2012
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
prostate cancer
prostatectomy
neoadjuvant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Dutasteride
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013