|
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer Clinical research trials and Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer. Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "N" Clinical Trials Conditions > Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer  Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
For Condition: perioperative/postoperative complications,sexual dysfunction and infertility,stage 2 prostate cancer,adenocarcinoma of the prostate,sexuality and reproductive issues,stage 1 prostate cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: Randomizedphase II trial to compare the effectiveness of nerve-sparing surgery with or without nerve grafting followed by standard therapy for erectile dysfunction in treating patients who are undergoing radical prostatectomy for localized prostate cancer.
Details: OBJECTIVES: - Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous nerve-sparing radical prostatectomy with vs without unilateral autologous interposition sural nerve grafting in patients with clinically localized prostate cancer. - Compare potency rates in patients treated with these regimens. - Compare erection quality in patients treated with these regimens. - Compare time to return of spontaneous erectile activity in patients treated with these regimens. - Compare the feasibility of these regimens in these patients. - Compare quality of life and sexual satisfaction in patients treated with these regimens. - Compare changes in penile erectile length and circumference in patients treated with these regimens. - Compare the relative morbidity of patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. - Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting. Beginning 6 weeks after surgery, patients undergo erectile dysfunction rehabilitation comprising any of the following: oral sildenafil (as occasion requires), use of vacuum erection device over 10 minutes once daily, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly, or MUSE (suppository in urethra for erections) therapy. Erectile dysfunction rehabilitation may continue for up to 2 years or until return of adequate spontaneous erectile activity. - Arm II: Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I. In both arms, treatment continues in the absence of unacceptable toxicity. Quality of life and sexual history are assessed at baseline, at 6 weeks postoperatively, at 4, 8, 12, and 16 months, and then every 4 months for 2 years or until return of spontaneous erectile activity. Patients are followed every 4 months for 2 years. PROJECTED ACCRUAL: A total of 200 patients (120 for arm I and 80 for arm II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of clinically localized adenocarcinoma of the prostate - T1-2, NX, M0 disease - Candidate for unilateral nerve-sparing radical retropubic prostatectomy - Gleason score 7 in the cores on the side to be spared - No discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts PATIENT CHARACTERISTICS: Age - 65 and under Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - No peripheral neuropathy that would preclude procurement of a sural nerve graft - No significant psychiatric illness - No demonstrable vasculogenic source of impotence PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No prior androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone agonists or antiandrogens) Radiotherapy - No prior pelvic irradiation Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherWood, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Christopher Wood 713-792-3250
Additional Information:
Study ID Numbers: CDR0000355366; MDA-ID-01304
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080808
Other Sexual Dysfunction And Infertility Studies:
1. Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
2. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
3. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
4. Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
5. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
Related Studies:
Other sexual dysfunction and infertility Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
|
|
|
|
|
|
|
|
