Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Prostatic Neoplasms

Chronic Disease

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Chronic Graft Versus Host Disease

Closely watching, waiting and treating symptoms if and when cancer progresses

Radical prostatectomy

Timothy J. Wilt, MD MPH

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Primary Hypothesis: To determine whether radical prostatectomy or expectant management is more effective in reducing mortality and extending life.

Secondary Hypothesis: To determine which treatment strategy is superior in terms of prostate specific cancer mortality, quality of life, occurrence or recurrence of symptoms and need for cancer treatment.

Intervention: 1) Radical prostatectomy, plus intervention for evidence of disease persistence or recurrence, 2) Expectant management with palliative therapy reserved for symptomatic or metastatic disease progression.

Primary Outcomes: All cause mortality.

Study Abstract: Cancer of the prostate (CAP) is the most common nondermatologic and the second most frequent cause of cancer deaths in men. No cure is currently possible for disseminated disease. Cancer confined to the prostate is believed to be curable, with the most frequently recommended therapy being surgical extirpation of the tumor with radical prostatectomy. However, despite increasing cancer detection and aggressive surgical treatment, population-based mortality rates from prostate cancer have not decreased, neither nationally nor in states with high rates of radical prostatectomy. Existing evidence does not demonstrate the superiority of this procedure compared to expectant management in the treatment of localized prostate cancer. Data from case series suggest that either treatment approach provides equivalent all-cause as well as prostate cancer specific mortality. The only randomized trial was limited by a small sample size but the results favored expectant management.

Radical prostatectomy provides potentially curative removal of the cancer. However, it subjects patients to the morbidity and mortality of the surgery and may be neither necessary nor effective. Expectant management does not offer potential cure. However, it provides palliative therapy for symptomatic or metastatic disease progression, avoids potentially excessive and morbid interventions in asymptomatic patients, and emphasizes management approaches for focus on relieving symptoms while minimizing therapeutic complications.

The primary objective of this study is to determine which of two strategies is superior for the management of clinically localized CAP: 1) radical prostatectomy with early aggressive intervention for disease persistence or recurrence, 2) expectant management with reservation of therapy for palliative treatment of symptomatic or metastatic disease progression. Outcomes include total mortality, CAP mortality, disease free and progression free survival, morbidity, quality of life, and cost effectiveness.

Prostate Cancer Intervention Versus Observation Trial (PIVOT)

CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer

Agency for Healthcare Research and Quality (AHRQ)

National Cancer Institute (NCI)

VA Office of Research and Development

Radical Prostatectomy

Watchful Waiting

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Timothy Wilt, MD

Surgical removal of the prostate

Radical prostatectomy: Surgical removal of the prostate

All Cause Mortality

Overall Study

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Heart and Blood Diseases

Diabetes Mellitus, Type 2

Kidney Diseases

Stroke

Diabetes Mellitus

Syndrome

Hypertension

Obesity

Metabolic Syndrome

Death

Sarcopenia

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Disease Attributes

Insulin Resistance

Hyperinsulinism

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Yuming Chen

Changyi Wang, PhD

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as cardio-metabolic diseases.

Study design: NECS is a community-based prospective cohort study. Participants: About 10000-20000 apparently healthy residents, living in Nanshan， Shenzhen (South China) for \>5 years, aged ≥ 65 years, will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examination, electrocardiogram test and specimen collection will be conducted.

Key variables:

1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics, lifestyles, habitual dietary intake, physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health and cognitive function.
2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
3. Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
5. Specimen collections: Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected and stored at -80°C till tests.
6. Laboratory tests:

   1. Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
   2. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
   3. Fecal test: Gut microbiota and related metabolites.
7. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
8. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as hypertension, type 2 diabetes mellitus, cardiovascular diseases, stroke, obesity, metabolic syndrome, chronic kidney disease, cancer and sarcopenia.

Study design: NECS is a community-based prospective cohort study. Participants: Healthy residents who had lived in Nanshan， Shenzhen (South China) for \>5 years, aged ≥ 65 years are eligible. Participants would be excluded if they are confirmed to have serious chronic diseases, such as cardiovascular disease, liver or renal failure, or cancer. About 10000-20000 apparently healthy residents will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examinations, electrocardiogram test and specimen collection will be conducted.

Key variables:

1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics (e.g., age, sex and household income, education level), lifestyles (smoking, passive smoking, alcohol and tea drinking), habitual dietary intake (a 62-item quantitative food frequency questionnaire), physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health (Self-Rating Anxiety Scale, SAS), social support and participation, cognitive function (Mini-Mental State Examinations, MMSE);
2. Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
3. Ultrasonography examinations: Ultrasonography examination of the carotid artery and upper abdominal organs (e.g., liver and kidney) will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
5. Specimen collections: Overnight fasting blood sample will be collected and separated into serum, plasma, red blood cell and leukocyte within two hours. Early morning first-void urine sample and faeces samples will be collected. All specimens will separated and stored at -80°C till tests.
6. Laboratory tests:

   1. Metabolic syndrome-related indices: Fasting serum lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), diabetes-related indices (e.g., glucose, glycated hemoglobin, fructosamine and insulin), uric acid and creatinine;
   2. Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
   3. Inflammatory markers (e.g., hsCRP, RBP4，IL-6, TNF-a)
   4. Sexual hormones (e.g., testosterone, SHBG)
   5. Genetic markers
   6. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
   7. Fecal test: Gut microbiota and related metabolites.
7. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
8. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Statistical analysis: Cox proportional hazards models or logistic regression models will be used to estimate the risk of exposures on categorical outcomes. Path analysis also will be used to assess the potential mediating effects in the causal pathway between exposures and outcomes.

Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected at baseline and follow-up。

Nanshan Elderly Cohort Study

Nanshan Elderly Cohort Study：a Community-based Prospective Cohort Study in Nanshan， Shenzhen Residents

The investigators will also track for occurrence of diabetes mellitus by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of cardiovascular diseases by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of stroke by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of cognitive disorder by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will measure metabolic syndrome-related indices at each visit (per every 3 years), the investigators can analysis the incidence of metabolic syndrome.

The investigators will measure fasting lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol) at each visit, and analyse the change of these indices.

The investigators will measure the handgrip strength, which will be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for handgrip strength (\<26 kg for men and \<18 kg for women).

The investigators will measure the usual gait speed., which will also be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for usual gait speed (\<0.8 m/s).

Shenzhen Nanshan Center for Chronic Disease Control

Sun Yat-sen University

Professor

Neoplasm Metastasis

Members of AARP, aged 50-71 years and who resided in one of six states or in two metropolitan areas in the United States

Rashmi Sinha, Ph.D.

Background:

The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality.

Objective:

To clarify links between diet, lifestyle, cancer, death, and chronic diseases.

Eligibility:

AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996.

Design:

This study will use existing data and samples. Participants will not be contacted.

Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID.

Data from other follow-up studies will be used.

Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well.

Cause of death and date of death will be obtained from the National Death Index.

Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome.

The University of Washington (UW) will be added as a study site. UW will study air pollution.

The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data.

Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.

Study Description

The purpose of this study is to analyze the data that have been collected as part of NIH-AARP study (OH95CN025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants.

Objective

To examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design

To examine relationships between diet, lifestyle, and mortality by means of a prospective cohort design

To examine relationships between diet, lifestyle, and chronic diseases

Study Population

Data and samples from 566,398 members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996

NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Cancer Intervention Versus Observation Trial (PIVOT)	NCT00007644	Prostate Cancer	Radical prostat...	- 75 Years	VA Office of Research and Development
Nanshan Elderly Cohort Study	NCT03569735	Hypertension Type 2 Diabetes... Cardiovascular ... Stroke Obesity Metabolic Syndr... Sarcopenia Chronic Kidney ... Cancer Death		65 Years -	Sun Yat-sen University
Prostate Cancer Intervention Versus Observation Trial (PIVOT)	NCT00007644	Prostate Cancer	Radical prostat...	- 75 Years	VA Office of Research and Development
Nanshan Elderly Cohort Study	NCT03569735	Hypertension Type 2 Diabetes... Cardiovascular ... Stroke Obesity Metabolic Syndr... Sarcopenia Chronic Kidney ... Cancer Death		65 Years -	Sun Yat-sen University
NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data	NCT04750915	Cancer Mortality Chronic Disease...		50 Years - 71 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for chronic diseases