Testosterone for Penile Rehab After Radical Prostatectomy

Condition(s) targeted: Low Testosterone Levels; Erectile Dysfunction

Intervention: Testim® + Viagra® (Drug); Placebo Testim® + Viagra® (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
Mohit Khera, MD, Principal Investigator, Affiliation: Baylor College of Medicine

Overall contact:
Sharon Harrison, Phone: 713-798-2240, Email: sharons@bcm.edu

The purpose of this study is to determine the effectiveness of testosterone replacement therapy (TRT) in men following surgery to remove the prostate in improving erectile function. Men scheduled for surgery to remove the prostate will be given the opportunity to take part in this study. Before surgery, subjects will complete questionnaires and have blood drawn. Subjects will be randomized (like flipping a coin) to one of two groups. One group will receive Testim® (testosterone gel) 5 g per day plus Viagra 25 mg every night and the other will receive Placebo-Testim® 5 g per day plus Viagra 25 mg every night.

Subjects will begin drug treatment 3 months after surgery and will take study drug for 3 months only. Office visits will be the 3, 6, 9, and 12 month visits. Participation will end at the end of the 12-month visit.

Official title: Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)

Study design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Primary outcome: The primary outcome of the study is to evaluate efficacy of testosterone replacement therapy (TRT) in men following radical prostatectomy in improving erectile function using the change in SHIM score at 6 months and 1 year after surgery.

Secondary outcome: The secondary outcome measure includes the change in the IIEF, ADAM and EPIC scores 1 year after surgery, the improvement trend in SHIM, IIEF, ADAM and EPIC scores over the 6 month and 12 months follow-up period.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Males, 18 years of age or older, with low testosterone levels.

- Must have undergone a bilateral nerve sparing radical prostatectomy.

- Nadir PSA values should be less than 0. 01 ng/ml on two consecutive occasions

separated by 4 weeks at the start of treatment.

- Must give informed consent.

- Must be willing to complete follow-up visits.

Exclusion Criteria:

- Testosterone level greater than 300 ng/ dl

- Hemoglobin level greater than 18 ng/dl.

- Pre-operative SHIM score less than 17. SHIM is a section within the International

Index of Erectile Function (IIEF) questionnaire.

- Positive surgical margins or evidence of residual prostate cancer.

- Clinically suspected advanced disease or actual evidence of metastatic prostate

cancer.

- Primary Gleason Grade greater than 3 or secondary Gleason Grade greater than 4 in the

final pathologic specimen will be excluded.

- Taking nitrates or with contraindications to the use of Viagra or androgen therapy

will be excluded.

- Known hypersensitivity to any component of the tablet will be excluded.

Sharon Harrison, Phone: 713-798-2240, Email: sharons@bcm.edu

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Larry I. Lipshultz, MD, Sub-Investigator

Related publications:

Khera M, Grober ED, Najari B, Colen JS, Mohamed O, Lamb DJ, Lipshultz LI. Testosterone Replacement Therapy Following Radical Prostatectomy. J Sex Med. 2009 Jan 22; [Epub ahead of print]

Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. Review.

Khera M. Androgens and Erectile Function: A Case for Early Androgen Use in Postprostatectomy Hypogonadal Men. J Sex Med. 2009 Jan 21; [Epub ahead of print]

Starting date: November 2007
Ending date: November 2013
Last updated: March 23, 2009