Trial of Modifications to Radical Prostatectomy
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Purpose
This study aims to determine how different ways of performing prostate cancer surgery affect patient outcomes, such as recurrence of cancer or regaining control of bladder function (continence) after surgery. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is uncertainty about some methods of surgery.
All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to what is the best approach. This trial will evaluate whether the following two aspects of surgical technique influence outcome:
Lymph node template. Prostate cancer can sometimes spread to the lymph nodes near the prostate. Surgeons often remove these lymph nodes to make sure that no cancer is left in the body. However, there is uncertainty about which lymph nodes to remove (the "template"). In particular, not all surgeons think that it is important to remove a large number of lymph nodes. Some believe that prostate cancer found in the lymph nodes is not aggressive. As a result, these surgeons feel that removing additional lymph nodes does not improve the chance that a patient will be cured. In the study patients will either have the standard lymph node dissection or a modified approach.
Fascial suturing. After surgery, patients can sometimes have long-term urinary incontinence. This is when a patient cannot control urine, and drips or leaks urine. Surgeons believe that what happens to the urethra (the tube that carries urine from the bladder to the penis) during surgery can affect the risk of incontinence. One idea is that additional stitches ("sutures") of the urethra to the connective tissue ("fascia") near the prostate during the surgery could be helpful, but this is not known for sure. In the study patients will either have the additional fascial suturing or no additional suturing.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: Fascial suturing Procedure: Lymph node template |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Modifications to Radical Prostatectomy |
- To compare the impact of anastomotic suturing with and without inclusion of the fascia on continence outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]Continence outcomes will be taken from patient-reported outcomes questionnaires; however, if a patient-reported outcome is not available, then physician-reported outcomes will be used. Continence is defined as a binary endpoint of no pad use at one year.
- To evaluate whether a modification to the template for lymph node dissection reduces biochemical recurrence rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]Biochemical recurrence is defined as any postoperative PSA of 0.2 ng / mL or higher, or treatment with hormones, radiotherapy or chemotherapy starting six months or more after radical prostatectomy.
| Estimated Enrollment: | 1400 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2021 |
| Estimated Primary Completion Date: | July 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fascial suturing
For patients randomized to either fascial suturing or no fascial suturing: after division of the dorsal venous complex and control of bleeding, the levator ani fibers are dissected away from the apex of the prostate exposing the urethra.
|
Procedure: Fascial suturing
Anastomotic suturing with and without inclusion of the fascia during a Radical Prostatectomy. Fascial suturing may aid return of continence by preventing hypermobility of the urethra.
|
|
Experimental: Lymph node template
In patients randomized to standard, only the nodal packet under the external iliac vein and above the obturator nerve will be dissected. For patients randomized to the modified template, the external iliac, hypogastric and obturator fossa nodal groups will be removed.
|
Procedure: Lymph node template
Inclusion of the external iliac, hypogastric and obturator fossa nodal groups in the template undergoing a Radical Prostatectomy. Modifying the template for lymph node dissection may lead to removal of additional affected nodes, reducing the chance of recurrence.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients do not have to be eligible for both modifications to be included in the study.
Fascial suturing:
- Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.
Template modification:
- Patients 21 years or older scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.
Exclusion Criteria:
Fascial suturing:
- No exclusion criteria.
Template modification:
- No exclusion criteria.
Contacts and Locations| Contact: Andrew Vickers, PhD | 646-735-8142 | |
| Contact: Peter Scardino, MD | 646-422-4329 |
| United States, New Jersey | |
| Memorial Sloan-Kettering Cancer Center at Basking Ridge | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Andrew Vickers, PhD 646-735-8142 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Andrew Vickers, PhD 646-735-8142 | |
| Contact: Peter Scardino, MD 646-422-4329 | |
| Principal Investigator: Andrew Vickers, PhD | |
| Principal Investigator: | Andrew Vickers, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01407263 History of Changes |
| Other Study ID Numbers: | 11-096 |
| Study First Received: | July 29, 2011 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
radical prostatectomy anastomotic suturing lymph node dissection 11-096 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013