Status:
COMPLETED
Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer
Lead Sponsor:
University of Michigan
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Surgical removal of the prostate (radical prostatectomy) is a common and generally effective treatment for prostate cancer. However, standard prostatectomy can affect urinary continence and sexual fun...
Detailed Description
Prostate cancer is the most common cancer diagnosed in men, and is increasingly managed with effective treatment strategies, including surgery. Although active treatment provides excellent cancer cont...
Eligibility Criteria
Inclusion
- Men with biopsy-proven histologic diagnosis of prostate adenocarcinoma
- Low risk for seminal vesicle invasions defined by:
- Clinical stage T1c/tumor 2-node 0-metastasis 0, Gleason score ≤ 6, PSA ≤ 10 ng/ml, positive prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage T1c/T2N0M0, Gleason ≤ 7, PSA ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)
- Sexually potent, defined as International Index of Erectile Function score ≥ 21, prior to randomization and surgery
- Competent to provide informed consent
- Able to read and write English
- Candidate for bilateral nerve-sparing
- Willing to be followed for 12 months post-surgery
Exclusion
- Intermediate or high risk for seminal vesicle invasion
- Unwilling to be randomized to either treatment arm
- Pre-operative treatment with radiation and/or hormone therapy
- Planned adjuvant radiation and/or hormonal therapy
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01825642
Start Date
September 1 2006
End Date
December 1 2012
Last Update
April 5 2013
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109