Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Vasodilator Agents

Urological Agents

All Drugs and Chemicals

Anticoagulants

Other Dietary Supplements

Sildenafil Citrate

Phosphodiesterase Inhibitors

Citric Acid

Sodium Citrate

Phosphodiesterase 5 Inhibitors

Enzyme Inhibitors

Citrate

Sildenafil (Viagra) 50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP hyperbaric oxygen therapy (90 minutes of 100% oxygen at 2.2ATA (equivalent to the pressure exerted at a depth of approximately 40 feet below sea level). There will be 5 or 10 treatments. The full treatment cycle will be completed within 2 weeks.

Sildenafil therapy plus post-NSRRP HBO2T

Sildenafil (Viagra)50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP sham hyperbaric oxygen therapy - 90 minutes at 2.2ATA but instead of 100% oxygen, they will receive air administered via the oxygen hoods, as if they were being administered oxygen. Participants in this group will receive 5 or 10 sham treatment sessions. Full treatment cycle will be completed within 2 weeks.

Sildenafil therapy plus sham post-NSRRP HBO2T

James Graydon, MD

The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra, Cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.

Prostate cancer is the most common non-skin malignancy in men in the United States, with approximately 232,000 diagnoses of adenocarcinoma projected for 2005. More than 150,000 of these men are treated with radical prostatectomy. Common sequelae following successful NSRRP (nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual dysfunction. Recent advances in surgery technique and treatment have been made but in spite of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth reporting return to baseline. The etiology of erectile dysfunction following radical prostatectomy results most probably from local surgical trauma and neurapraxia, which leads to corpus cavernosal hypoxemia in the post-NSRRP period. This hypoxemia is believed to impact negatively on the health and maintenance of the smooth muscle cells within the corpus cavernosum. Hyperbaric oxygen therapy (HBO2T) is a unique modality that is able to provide oxygen delivery to tissues that have been damaged by traumatic injury.

Hypothesis: The addition of post-NSRRP hyperbaric oxygen therapy (HBO2T) to a treatment of phosphodiesterase type 5 inhibitor (PDE5I) will reduce the incidence of erectile dysfunction (ED) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-NSRRP for Stage I prostate cancer.

Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy

Hartford Hospital

Carcinoma

GPI 1485

Antonella Favit-Van Pelt, MD, PhD

In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.

This drug has been tested in animals, and was shown to protect nerves from damage and to regrow damaged nerves in these animal studies. Participants will receive either GPI 1485 or a placebo (inactive pill). Participants will begin study medication 3 full days prior to their scheduled surgery.

GPI 1485 will be supplied as an oral tablet formulation to men who are candidates for bilateral nerve-sparing prostatectomies. Participants randomly assigned to receive GPI 1485 will be required to take four tablets four times a day by mouth.

GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants randomly assigned to placebo will be required to take 4 placebo tablets four times a day by mouth.

Viagra® will be supplied as oral tablets beginning 1 month post-surgery. Patients can begin Viagra® 1 month post-surgery and may continue use until the end of the study, as needed.

The duration of this study is 12 months which includes 5 office visits to your doctor in addition to the surgery day. During this study you will also have other clinical evaluations including a physical exam, blood work, ECG (tracing of your heart rhythm) and urinalysis.

Participants enrolled in this study will also carry a handheld diary that is loaded with special protocol-specific software, which will be referred to as the patient experience diary (PED). Over the duration of this study, participants will complete their questionnaires and answer questions about their medication compliance in the electronic PED.

Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy

Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma

Symphony Neuro Development Company

Eisai Inc.

Adenocarcinoma

Platelet Aggregation Inhibitors

Micronutrients

Lipid Regulating Agents

Vitamins

Pentoxifylline

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Atorvastatin

Trace Elements

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antioxidants

Protective Agents

Radiation-Protective Agents

Tocopherol

Tocotrienol

Patients receive atorvastatin PO QD for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity.

Vitamin E Compound

Chad Tang

This phase II trial studies how well pentoxifylline, atorvastatin, and vitamin E (PAVE) work in treating patients with erectile dysfunction after radiation therapy for prostate cancer. Atorvastatin may reduce high cholesterol. Pentoxifylline and vitamin E may enhance blood flow. Giving PAVE may work better in treating prostate cancer patients with post-radiation therapy erectile dysfunction.

PRIMARY OBJECTIVE:

I. To estimate the proportion of patients who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of atorvastatin or patient's currently prescribed statin, vitamin E, and pentoxifylline (PAVE).

SECONDARY OBJECTIVES:

I. To report the safety profile of PAVE. II. To report the rate of choosing other ED treatments after PAVE.

OUTLINE:

Patients receive atorvastatin orally (PO) once daily (QD) for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO thrice daily (TID) for up to 12 months in the absence of disease progression or unacceptable toxicity.

Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer

Pentoxifylline, Atorvastatin, and Vitamin E (PAVE) as Treatment for Radiation-Induced Erectile Dysfunction

To estimate the proportion of participants who achieve a clinically significant improvement in erectile dysfunction (ED) when treated with a combination of Atorvastatin or participant's currently prescribed statin, Vitamin E, and Pentoxifylline (PAVE)

The safety profile of the pentoxifylline, atorvastatin and vitamin E (PAVE) combination will be reported for each cohort, with adverse events summarized by grade and time to onset to first grade 3 adverse event.

To report the rate of choosing other ED treatments after PAVE.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Participants not on any statin and were started on Atorvastatin 10 mg 1 tab daily with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.

Cohort 1

Participants were on some amount of Atorvastatin and the dosage ramined the same With addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.

Cohort 2

Participants on some other statin beside atorvastatin and the dosage remained the same with addition of receiving Pentoxyfilline 400 mg 1 tab 3 times daily and Vitamin E 1000units 1 tab daily.

Cohort 3

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Chad Tang, Associate Professor, Radiation Oncology Department

The data shows that 0 participants achieved any clinically significant improvement.

Change in International Index of Erectile Function (IIEF) Scores

Serious Adverse Event

Adverse Event

Number of Participants With Incidence of Adverse Events (AEs)

Choosing Other Erectile Dysfunction (ED) Treatments After Pentoxifylline, Atorvastatin and Vitamin E (PAVE)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer	NCT00906269	Impotence Prostatic Neopl...	Sildenafil ther... Sildenafil ther...	40 Years - 65 Years	Hartford Hospital
Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy	NCT00090376	Impotence Prostate Cancer	GPI 1485	40 Years - 69 Years	Eisai Inc.
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer	NCT00906269	Impotence Prostatic Neopl...	Sildenafil ther... Sildenafil ther...	40 Years - 65 Years	Hartford Hospital
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer	NCT03830164	Male Erectile D... Prostate Adenoc... Erectile Dysfun... Impotence	Atorvastatin Pentoxifylline Vitamin E Compo...	18 Years -	M.D. Anderson Cancer Center
Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer	NCT00906269	Impotence Prostatic Neopl...	Sildenafil ther... Sildenafil ther...	40 Years - 65 Years	Hartford Hospital

Spots Global Cancer Trial Database for impotence

Every month we try and update this database with for impotence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for impotence

Every month we try and update this database with for impotence cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for impotence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.