Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Contrast-enhanced Ultrasound

All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.

Perflutren lipid

Kimryn Rathmell, MD

Wui Chong, MBBS, FRCR

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).

This prospective pilot study is designed to evaluate the accuracy of contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) when used to evaluate renal lesions in two different populations; patients with known renal tumors (Cohort 1) and patients with a risk factor for renal malignancy in whom their screening ultrasound shows an indeterminate or possibly malignant renal mass (Cohort 2).

Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer

LCCC 1219: A Prospective Pilot Study Evaluating Renal Lesions Through Contrast-enhanced US in Patients With Renal Cancer and in Those With a Risk Factor for Renal Malignancy

Primary analyses will include 1) estimating the sensitivity of contrast enhanced ultrasound in Cohort 1 using the pathological outcome or biopsy result from ablative therapy as gold standard and 2) estimating sensitivity in Cohort 2 using pathology and follow-up results as gold standard (when tissue biopsy is not indicated nor surgery planned the truth standard diagnosis will be based on 12 month follow-up data of disease status). Exact 95% confidence intervals for sensitivity estimate will be reported.

The estimates obtained in Cohort 1 will be compared to the published figures of the conventional CT and MRI method. For Cohort 2 patients who undergo surgery, the percentage of subjects who are correctly diagnosed (benign and malignancy) will be reported along with exact 95% CI. Frequency tables will be used to describe associations. Appropriate descriptive summary statistics such as mean, median and standard deviation of tumor measurement will be provided to quantify and characterize renal masses.

UNC Lineberger Comprehensive Cancer Center

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

The exercise intervention will consist of a combination of aerobic (cardiovascular exercise) and strength training (emphasis of the intervention) 3 times per week for 12 weeks with each session lasting \~1.5 hours.

Participants in the Non-Exercise Control Arm will not exercise for 12 weeks.

Exercise

Anthony C Hackney, Ph.D., D.Sc.

This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.

This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy. The investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.

Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

Randomized, Controlled Study of an Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Either Abiraterone or Enzalutamide

DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention.

Symptoms and General Pathology

Pain

Analgesics

All Drugs and Chemicals

Antineoplastic Agents

Docetaxel

Surveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer

Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).

Survey

Ethan Basch, MD

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.

This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. The study aims to address several key methodological questions that will inform the design of future clinical trials with symptom endpoints in this population, including: the definition of "clinically meaningful" pain; criteria for concluding a clinically meaningful pain reduction; criteria for concluding clinically meaningful pain progression; reliable methods quantifying analgesic use (given that "equianalgesic tables" and "point scoring systems" are generally considered unreliable by pain researchers and regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different frequencies of symptom reporting; symptom trajectories over time; and associations of pain scores with other metrics used in prostate cancer research (imaging, PSA values, circulating tumor cells, etc).

Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.

Determine the clinical significance of pain score changes. Pain score changes will be compared with each of the following "anchors": patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). ROC curves derived using logistic regression analyses will be used to characterize the association between change in pain scores and clinically important improvement (defined by anchor variables).

Descriptive statistics, including Kaplan-Meier, will be used to report findings for the proportion of asymptomatic men who ultimately develop pain, the median time until asymptomatic men develop pain, the median time until men with pain experience pain progression, and the median time until men with pain experience pain palliation.

Three different approaches to calculating a single value to represent total analgesic use will be compared: 1) equianalgesic tables published in guidelines of the National Comprehensive Cancer Network (NCCN) which convert various drugs and doses to "morphine equivalents"; 2) point scoring systems used in prior pivotal phase 3 trials based on the World Health Organization analgesic ladder in which lower points are assigned to weaker agents/doses and vice versa for stronger agents/doses; and 3) individual drug dose quantification, a dose recently suggested by the FDA but never empirically evaluated, in which each analgesic is considered individually and a 25% change in dose is considered an increase or decrease for each.

Seven consecutive days of reporting a pain item with a 24-hour recall item will be compared with a single administration of a pain item with a 7-day recall, in order to evaluate if the latter alone is sufficient for measuring pain.

Identify the web-avidity of patients by summarizing patients' responses to questionnaire items about their use of internet and email.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer	NCT01751529	Kidney Cancer	Contrast-enhanc... Perflutren lipi...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Open-label Pilot Evaluating Renal Lesions w/ Contrast-enhaced US in Patients w/ Renal Cancer	NCT01751529	Kidney Cancer	Contrast-enhanc... Perflutren lipi...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide	NCT02130947	Metastatic Cast...	Exercise	18 Years -	UNC Lineberger Comprehensive Cancer Center
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer	NCT02008058	Metastatic Cast...	Survey	18 Years -	UNC Lineberger Comprehensive Cancer Center

Spots Global Cancer Trial Database for unc lineberger