Recruiting
Phase 3

Erectile Recovery

Sponsor:

Brooke Army Medical Center

Code:

NCT03406169

Conditions

Erectile Dysfunction

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Sildenafil 25 MG Oral Tablet

Pentoxifylline

Placebo

Study Details

Brief summary:

The study is a prospective, randomized, double-blind, placebo-controlled drug study to evaluate the pattern of erectile function recovery after robotic assisted laparoscopic prostatectomy (RALP). We hope to illustrate that early and continuous therapy with either Sildenafil citrate or pentoxyfylline after nerve sparing RALP will promote improved erectile function.

Conditions

Erectile Dysfunction

Prostate Cancer

Study ID

NCT03406169

Start date

Feb 13, 2017

Status verified date

Jan, 2018

Completion date

Mar, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients who have had a prostate biopsy positive for prostate cancer.
2. Patient must be age 30 - 89 years.
3. Patient must be willing to sign the Institutional Review Board approved consent.
4. Patient must have had (or be about to undergo) bilateral or unilateral nerve sparing RALP.
5. Patient must have an International IIEF equal to or greater than 21.

Exclusion Criteria:

1. Patients with known unstable angina, uncontrolled hypertension, congestive heart failure, or cardiovascular accident within the preceding 2 weeks.
2. Patients being treated with nitrate therapy.
3. Patients with significant renal or hepatic impairment, cerebrovascular disease.
4. Patients with prior erectile dysfunction as indicated by the initial IIEF.
5. Patients younger than 30 years of age.
6. Patients who did/will not have a unilateral or bilateral nerve sparing radical prostatectomy.
7. Patients who have had a prior reaction to Sildenafil or pentoxifylline.
8. Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc.).
9. Patients with a clinically significant abnormality on preoperative ECG that in the opinion of the investigator may increase the patient's cardiovascular risk in this study.
10. Patients with a history of left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis).
11. Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg).
12. Patients with retinitis pigmentosa.
13. Patients with a bleeding disorder.
14. Patients with active peptic ulceration.
15. Patients with conditions that may predispose to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia).
16. Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sildenafil 25mg Oral Tablet

25mg sildenafil citrate twice daily

active comparator: Pentoxifylline

400mg pentoxifylline twice daily

placebo comparator: Placebo

placebo twice daily

Interventions

Sildenafil 25 MG Oral Tablet

twice a day dosing

Pentoxifylline

400mg twice a day

Placebo

placebo twice a day

Primary outcome measure

  • Erectile function [ Time Frame: 12 months post surgery ]

Central Contacts and Locations

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Jan 23, 2018

Last verified

Jan, 2018

Keywords

  • penile rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2018-01-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.