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Study of Anatomic Nerve Sparing Radical Perineal Prostatectomy

Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00922818
Acronym
RPP
Enrollment
0
Registered
2009-06-17
Start date
2009-06-30
Completion date
2011-05-26
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Perineal, Prostatectomy, Nerve, Anatomic, Surgery, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer, Prostate, Cancer, Recurrent

Brief summary

Our objective is to evaluate the clinical outcomes for the anatomic radical perineal prostatectomy (RPP) for the surgical management of prostate cancer. We will report the perioperative, oncologic, and functional outcomes in patients undergoing the radical perineal prostatectomy at our institution.

Detailed description

The purpose of our study is to evaluate perioperative, oncologic, and functional outcomes for the anatomic radical perineal prostatectomy. The anatomic radical perineal prostatectomy is standard-of-care surgical approach to the surgical management of localized prostate cancer. The operative technique selected for radical prostatectomy is largely based on patient preference after appropriate counseling, and surgeon recommendation based on surgical considerations and surgeon experience. Outcome data for the anatomic radical perineal prostatectomy will represent a valuable addition to the published body of literature. Our study is a prospective clinical outcome data collection and analysis and we will be looking at data within several domains. First, perioperative data will be collected to evaluate the OR time, blood loss, surgical complications, and length of hospital stay for the anatomic radical perineal prostatectomy. Second, oncologic efficacy of this procedure will be reported, based on margin status of surgical specimens, which will be correlated with tumor features (Gleason score, tumor volume, pre-op PSA score). Third, functional outcomes will be evaluated by comparing urinary, sexual, and bowel function in the pre-op and post-op settings. This third domain will be accomplished by employing the following validated questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be filled out at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.

Interventions

None listed

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age * Perineal prostatectomy for prostate cancer at Maimonides Medical Center

Exclusion criteria

* Dementia

Design outcomes

Primary

MeasureTime frameDescription
Surgical margin-free rateJune 2011proportion of negative margins

Secondary

MeasureTime frameDescription
EPIC-26 Functional Outcome StatusJune 2011validated outcome questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026