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Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Primary Purpose

Erectile Dysfunction, Prostate Cancer

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Sildenafil 25 MG Oral Tablet

Pentoxifylline

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring penile rehabilitation

Eligibility Criteria

30 Years - 89 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Brooke Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sildenafil 25mg Oral Tablet

Pentoxifylline

Placebo

Arm Description

25mg sildenafil citrate twice daily

400mg pentoxifylline twice daily

placebo twice daily

Outcomes

Primary Outcome Measures

Erectile function

As measured by IIEF

Secondary Outcome Measures

Penile length

Stretched length in cm from pubis to coronal ridge

Full Information

NCT ID

NCT03406169

First Posted

January 16, 2018

Last Updated

January 19, 2018

Sponsor

Brooke Army Medical Center

Collaborators

Walter Reed National Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03406169

Brief Title

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Official Title

Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 13, 2017 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

Collaborators

Walter Reed National Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Evaluation of erectile function with the International Index of Erectile Function Questionnaire (IIEF) and measurement of penile length any time between the prostate biopsy and 3 days prior to RALP will be performed. Patients will undergo a unilateral or bilateral nerve sparing-RALP. Patients will be randomized to receive either 25mg Viagra twice daily, 400mg pentoxifylline twice daily or placebo twice daily, starting on the first postoperative day after surgery and continuing for one year. The biostatistician generates a table of random numbers. 120 subjects anticipated to enroll at Brooke Army Medical Center will be divided into 3 groups, sildenafil, pentoxifylline or placebo. The randomization table will be given to the research pharmacist. Patients will have their erectile function evaluated at 3 months, 6 months, 9 months, and 12 months with IIEF and sexual intercourse diary. These visits are routine for post-operative care following a RALP, however, completion of the IIEF and sexual intercourse diary are being performed for study purposes. Patients will stop therapy at 12 months and penile length will be re-measured. Measurement of penile length will be done for study purposes at the standard 1 year post-operative follow up visit. Patient will undergo a 6 week washout period during which neither drug will be used, then repeat analysis of erectile function with IIEF will be performed, after which they may restart standard erectile dysfunction therapy as desired. This washout period and follow up will be for study purposes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction, Prostate Cancer

Keywords

penile rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil 25mg Oral Tablet

Arm Type

Active Comparator

Arm Description

25mg sildenafil citrate twice daily

Arm Title

Pentoxifylline

Arm Type

Active Comparator

Arm Description

400mg pentoxifylline twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo twice daily

Intervention Type

Drug

Intervention Name(s)

Sildenafil 25 MG Oral Tablet

Other Intervention Name(s)

viagra

Intervention Description

twice a day dosing

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline

Other Intervention Name(s)

trental

Intervention Description

400mg twice a day

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

placebo twice a day

Primary Outcome Measure Information:

Title

Erectile function

Description

As measured by IIEF

Time Frame

12 months post surgery

Secondary Outcome Measure Information:

Title

Penile length

Description

Stretched length in cm from pubis to coronal ridge

Time Frame

12 months post surgery

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Must have a prostate

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have had a prostate biopsy positive for prostate cancer. Patient must be age 30 - 89 years. Patient must be willing to sign the Institutional Review Board approved consent. Patient must have had (or be about to undergo) bilateral or unilateral nerve sparing RALP. Patient must have an International IIEF equal to or greater than 21. Exclusion Criteria: Patients with known unstable angina, uncontrolled hypertension, congestive heart failure, or cardiovascular accident within the preceding 2 weeks. Patients being treated with nitrate therapy. Patients with significant renal or hepatic impairment, cerebrovascular disease. Patients with prior erectile dysfunction as indicated by the initial IIEF. Patients younger than 30 years of age. Patients who did/will not have a unilateral or bilateral nerve sparing radical prostatectomy. Patients who have had a prior reaction to Sildenafil or pentoxifylline. Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc.). 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. Patients with a history of left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis). Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg). Patients with retinitis pigmentosa. Patients with a bleeding disorder. Patients with active peptic ulceration. Patients with conditions that may predispose to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia). Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Janet Schadee, RN

Phone

210 916-1640

janet.s.schadee.civ@mail.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Pansy Uberoi, MD

Phone

210 916-1163

pansy.uberoi.mil@mail.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kuwong B Mwamukonda, MD

Organizational Affiliation

Brooke Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ileana King-Letzkus

Phone

210-916-2000

ileana.e.king-letzkus.civ@mail.mil

12. IPD Sharing Statement

Learn more about this trial

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

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