Patients undergo BOLD fMRI and receive papaverine hydrochloride IV on day 1. Within 30-90 minutes, patients undergo a second BOLD fMRI. Patients then receive papaverine hydrochloride IV and within 30-90 minutes after dose undergo SBRT for a up to 4-5 sessions over 2 weeks.

Lung Non-Small Cell Carcinoma

Blood Oxygen Level Dependent Imaging

Papaverine Hydrochloride

Stereotactic Body Radiation Therapy

Ohio State University Comprehensive Cancer Center

Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases

A Phase I Trial Combining Papaverine and Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer or Lung Metastases

Will employ the Bayesian optimal interval (BOIN) design to find the MTD.

Primary tumor control is defined as the absence of primary tumor failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Local control is defined as the absence of local failure. Will be calculated and 95% exact binomial confidence interval will be provided.

Will be summarized using Kaplan-Meier method.

Will be measured before and after papaverine hydrochloride (PPV) delivery by the percentage change in relaxation rate on MRI. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of analysis of variance (ANOVA) for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.

Will analyze patient serum pre-and post-treatment for hypoxia-associated at pre- and post- SBRT treatment hypoxia-inducible microRNAs (miRs) using nanoString miRNA assay that could indicate the presence of tumor hypoxia. The changes in circulating biomarkers will be validated by alternative quantitative polymerase chain reaction (qPCR) based approaches. These results will be cross-validated with the BOLD data. Will also analyze biomarkers descriptively and graphically to assess trends in changes in these markers over time and the association with response. Exploratory comparisons of groups of patients based on response will involve the use of ANOVA for continuous data and categorical methods such as Fisher?s exact and chi-square tests for discrete data.

Terence Williams

Principal Investigator

National Cancer Institute (NCI)

Coloverin (Mebeverine hydrochloride 135 mg)

Oncology

Incontinence

Incontinence, Daytime Urinary

Incontinence, Nighttime Urinary

Bladder Cancer

Orthotopic Neobladder

Coloverin

Placebo

Urology and Nephrology Center

Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders

Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study

Outcome Measure by standardized continence questionnaire

Outcome Measure by quality of life questionnaire

Outcome Measure by pressure change measurement in centimetre of water.

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Mansoura University

Prostatic Hyperplasia

papaverine

Prostatic Hyperplasia Treatment and Cancer Prevention

Treatment of Prostatic Hyperplasia With Topical Papaverine

DR. VINOD C TAWAR

Manchanda Medical Clinic

Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.

Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.

Prostate Cancer

Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly

Alprostadil (E1)

Papaverine

Phentolamine mesylate

Sildenafil citrate

Unilateral cavernous nerve sparing radical retropubic prostatectomy

conventional surgery

M.D. Anderson Cancer Center at University of Texas

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

A Randomized Phase II Trial Evaluating the Importance of Early Erectile Dysfunction Rehabilitation and Unilateral Autologous Sural Nerve Sparing Radical Prostatectomy Clinically Localized Prostate Cancer

papaverine/rakovina

Papaverine and Stereotactic Body Radiotherapy (SBRT) for Non Small Cell Lung Cancer (NSCLC) or Lung Metastases

Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders

Prostatic Hyperplasia Treatment and Cancer Prevention

Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer

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