CompletedPhase 2

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

United States111 participantsStarted 2001-08

Plain-language summary

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: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.

Who can participate

Age range

65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient must be a candidate for a unilateral nerve sparing radical retropubic prostatectomy. a) Gleason score 7 or less in the cores on the side to be spared
. Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts.
. Patient must be \</= 65 years of age at the time of study enrollment.
. Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft
. Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence.
. No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists or anti-androgens)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Potency rate at 2 years after surgery

Timeframe: 2 years

Trial details

NCT IDNCT00080808

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-07

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