Clinical trial NCT00848497: Testosterone for Penile Rehabilitation After Radical Prostatectomy
Official title: Efficacy of Testosterone Replacement Therapy in Penile Rehabilitation Following Radical Prostatectomy (#: 04-07-30-01)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Hypogonadism
Erectile Dysfunction
Keywords: hormone replacement therapy
radical prostatectomy
erectile dysfunctions
scheduled for removal of prostate gland
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. 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 the initial screening visit and will take study drug for 3 months only. Participation will end at the end of the 6-month visit.

Detailed description: There was only one patient who began treatment with the study drug. After blind was broken, it was noted that he received placebo Testim and Viagra.

Eligibility 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 (Prostate-Specific Antigen) 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.
* Positive surgical margins or evidence of residual prostate cancer after surgery.
* 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.

Primary outcomes:
measure: Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.
timeFrame: Baseline and 6 months
measure: Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.
timeFrame: Baseline and 6 months
measure: Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.
timeFrame: Basline and 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mohit Khera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khera M, Grober ED, Najari B, Colen JS, Mohamed O, Lamb DJ, Lipshultz LI. Testosterone replacement therapy following radical prostatectomy. J Sex Med. 2009 Apr;6(4):1165-1170. doi: 10.1111/j.1743-6109.2009.01161.x. Epub 2009 Jan 22.
citation: Khera M, Lipshultz LI. The role of testosterone replacement therapy following radical prostatectomy. Urol Clin North Am. 2007 Nov;34(4):549-53, vi. doi: 10.1016/j.ucl.2007.08.007.
citation: Khera M. Androgens and erectile function: a case for early androgen use in postprostatectomy hypogonadal men. J Sex Med. 2009 Mar;6 Suppl 3:234-8. doi: 10.1111/j.1743-6109.2008.01159.x. Epub 2009 Jan 21.