A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological Complete Response Rate
Outcome Description:
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
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MDV3100-07
NCT ID:
NCT01547299
Start Date:
March 2012
Completion Date:
August 2013
Related Keywords:
- Prostate Cancer
- prostate cancer
- prostatectomy
- neoadjuvant
- Prostatic Neoplasms
Name | Location |
|---|---|
| Seattle, Washington 98195 | |
| Boston, Massachusetts |
