Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

Older men who were treated for localized or locally advanced prostate cancer with curative intent at the age of 70 years or more

Existing population based data from men who participated in the Trøndelag Health Survey 2017-2019, matched on age and education

Marit Slaaen, PhD

Ola Berger Christiansen, PhD

The present study is the last part of a larger project investigating the health, quality of life and function of men having received radical treatment for prostate cancer in 2014-2018. In this study, physical function and level of physical activity will be tested and registered in a selection of older men who participated in the foregoing parts of the project. Comparisons will be made to similar data from a population-based cohort, matched on age and education.

Background:

Prostate cancer is the most common cancer among Norwegian men with about 5000 new cases each year. Median age at diagnosis is 70 years. Radical treatment for local or locally advanced prostate cancer is either radiotherapy or surgery. Older men more frequently have an aggressive cancer compared to younger men. Despite this, increasing age seems to be a major determinant for omitting curative treatment. Reasons may be worries about side effects in a more vulnerable population, and scarce knowledge about the long-term impact of radical treatment on the older patients' health, function, and quality of life.

Design:

The study is the last part of larger project investigating the health status, quality of life, and function among survivors after radical prostate cancer treatment, focusing on older survivors in particular (NCT04863352). In this study, physical function, physical activity, quality of life, and cardiopulmonary fitness will be evaluated in a subgroup of those men who participated in the foregoing parts of the overarching project, and who were 70 years or more when they received their treatment. The study has a cross-sectional design, and for comparison with a general population, existing data from male participants in the fourth wave of the Trøndelag Health Survey (HUNT4) will be used. The control group will be matched with the study group on age and education, with a distribution 1:3 (cancer survivors : controls).

Aims:

The primary study aim is to investigate if objectively assessed physical performance, physical and sedentary activity in older prostate cancer survivors differ from that of a general male population of the same age.

The secondary aim is to investigate whether and how objectively assessed physical performance is associated with QoL and self-reported physical function and activity.

Study conduct:

To be invited is a random sample of older participants (\>70 years old by the time of treatment) in the foregoing parts of the overarching project, stratified by actual age combined with age at treatment. Consenting participants will be invited to testing, which will take place at various hospital locations. The testing will include registration of weight and height, waist circumference, and resting heart rate. Physical performance will be tested by the Short Physical Performance Battery (SPPB), one-legged balance test, and grip strength. Registration of physical- and sedentary activity will be performed using the accelerometer Axivity AX3, which assesses time spent sitting, lying, standing, walking, running, etc. Participants will wear two devices on all waking hours for seven days, one attached to their hip and one to their back. The registrations will be transferred to a designated software for analysis. The participants will also answer a short questionnaire including items on self-reported physical activity and quality of life. Testing is estimated to take about 30-45 min. A PhD student (MD) and a project nurse will perform the testing, instruct the participants how to wear the accelerometers, and to return the devices in a pre-paid envelope. Consenting participants, unable to meet at the arranged occasions, will be tested locally/at home by trained community cancer nurses/physiotherapists.

Statistics:

SPPB scores (primary outcome) will be compared between the older prostate cancer survivors and their matched controls by bivariate linear regression model. Adjustments will be made for potential pre-defined confounders (social status, comorbidity scores, and health status) and matching variables (age and education) to avoid the residual confounding in a multiple linear regression model. Secondary outcomes will be assessed in the same way as the primary ones for each objective. The type of regression model will be considered based on the nature of each outcome analysed.

Sample size: According to Green's rule of thumb, with 10 variables in the multiple model at least 130 participants will be needed to obtain valid estimates. To cover for possible registration failures for some participants, a random sample of 150 consenting older participants who fulfill the inclusion criteria and thrice as many matched controls will be included.

Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. Part IIB

Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. A Cross-sectional Study Focusing on Older Survivors. Part IIB

According to Norwegian Privacy Protection regulations, data cannot be shared as long as they are not anonymised. However, insight into all data is possible by visiting our research site

Physical performance as measured by the short physical performance battery (SPPB)

Physical Activity as registered by accelerometer AX3 Axivity

Sedentary activity as registered by accelerometer AX3 Axivity

test assessing the participants ability to balance on one leg

CRF as estimated from age, gender, BMI/waist circumference, resting heart rate and and physical activity (self-reported, item from the Trøndelag Health Survey)

physical function as measured by the European Organisation for Research and Treatment of Cancer Quality of life questionnaire - C30 (EORTC QLQ-C30)

global quality of life as measured by the EORTC

self-reported physical activity as measured by items for the Trøndelag Health Survey

Norwegian University of Science and Technology

Sykehuset Innlandet HF

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Tislelizumab + S1 + Radiotherapy Drug: Tirellizumab IV infusion，200 mg/3w, for 1 year

Drug: S1 PO, 40\~60mg，BID（d1-14，d22-35，two cycles）

Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f

S1 + Radiotherapy

Drug: S1 PO, 40\~60mg，BID（d1-14，d22-35，two cycles）

Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f

Arm A

Radiation Concurrent Radiation, 1.8Gy/f, 28f

Arm B

Wencheng Zhang, M.D.

Ke Zhang, M.D

Wen Cheng, M.D.

Wencheng Zhang, M.D

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation.

Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown.

In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC

Tislelizumab Combined With Concurrent Chemoradiation Versus Concurrent Chemoradiation for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Parallel-controlled, Multicenter Phase II Clinical Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. Part IIB	NCT05200039	Prostate Cancer Survivorship Physical Functi... Physical Activi... Old Age		70 Years -	Sykehuset Innlandet HF
Health Status, Quality of Life and Function in Survivors After Radical Treatment for Prostate Cancer. Part IIB	NCT05200039	Prostate Cancer Survivorship Physical Functi... Physical Activi... Old Age		70 Years -	Sykehuset Innlandet HF
Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC	NCT06061146	Esophageal Canc...	Arm A Arm A Arm A Arm B Arm B	70 Years - 90 Years	Tianjin Medical University Cancer Institute and Hospital
Tislelizumab Plus Concurrent Chemoradiation in Older With ESCC	NCT06061146	Esophageal Canc...	Arm A Arm A Arm A Arm B Arm B	70 Years - 90 Years	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for old age

Every month we try and update this database with for old age 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 old age

Every month we try and update this database with for old age 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 old age 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.