NCT03406169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

4.8 years

First QC Date

January 16, 2018

Last Update Submit

January 19, 2018

Conditions

Erectile DysfunctionProstate Cancer

Keywords

penile rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Erectile function

    As measured by IIEF

    12 months post surgery

Secondary Outcomes (1)

  • Penile length

    12 months post surgery

Study Arms (3)

Sildenafil 25mg Oral Tablet

ACTIVE COMPARATOR

25mg sildenafil citrate twice daily

Drug: Sildenafil 25 MG Oral Tablet

Pentoxifylline

ACTIVE COMPARATOR

400mg pentoxifylline twice daily

Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR

placebo twice daily

Other: Placebo

Interventions

Sildenafil 25 MG Oral TabletDRUG

twice a day dosing

Also known as: viagra
Sildenafil 25mg Oral Tablet
PentoxifyllineDRUG

400mg twice a day

Also known as: trental
Pentoxifylline
PlaceboOTHER

placebo twice a day

Placebo

Eligibility Criteria

Age30 Years - 89 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMust have a prostate
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionProstatic Neoplasms

Interventions

Sildenafil CitrateTabletsPentoxifylline

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsProstatic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical PreparationsTheobromineXanthinesPurinones

Study Officials

  • Kuwong B Mwamukonda, MD

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Schadee, RN

CONTACT

210 916-1640janet.s.schadee.civ@mail.mil

Pansy Uberoi, MD

CONTACT

210 916-1163pansy.uberoi.mil@mail.mil

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Urologist

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 23, 2018

Study Start

February 13, 2017

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)