Clinical Trials Logo

Clinical Trial Summary

In this study, addressing prostate cancer survivors, i.e. men who received potentially curative (radical) treatment two to six years ago, we will investigate if older age at time of treatment is a detrimental factor with respect to long-term quality of life (Qol), health, and function. We will also compare QoL, health and function between the prostate cancer survivors and matched population based cohorts, and thereby provide realistic information on the long-term impact of radical prostate cancer treatment

Clinical Trial Description

Prostate cancer is the most common male cancer in Norway, with almost 5000 new cases yearly. More than12 % of men contract prostate cancer before the age of 75. As 5-year survival is high (>95%), a significant proportion of the older male population are prostate cancer survivors. The quality of life (QoL) and daily function of these older males need elucidation to provide adequate health care services and information to this large patient group. The present project includes two studies(Study I and IIA). Study I is investigating the QoL, health status, and local adverse treatment effects in all men 2-6 years after radical treatment for prostate cancer. Local adverse treatment effects are defined as problems related to organs and structures adjacent to the prostate gland (e.g. bowel and urinary problems, and sexual dysfunction). Study IIA will focus on older prostate cancer survivors, defined as men who were 70 years or older by the time of treatment. To complete the overall project, we also plan a later study, Study IIB, that will investigate in more detail the physical functioning and performance of the older survivors. Design Study I: A cross-sectional survey targeting all patients from the catchment area of Innlandet Hospital Trust (SI-HF) who received radical treatment for localized/locally advanced prostate cancer at SI-HF from 2014 to 2018 Study II A: A supplementary cross-sectional survey targeting older participants from Study I who were >70 years at time of treatment Control groups: For comparison with a general population, we will use existing data from male participants in the fourth wave of the Trøndelag Health Study (HUNT4) including the HUNT4 70+ survey. Control groups will be drawn, matched on age and education. HUNT4 and HUNT4 70+ were both performed in 2017-2019, and targeted all inhabitants and inhabitants >70 years respectively in the former Nord-Trøndelag County. Jointly they include broad health assessments using questionnaires, physical examinations, and tests. Study aims Primary study aims are 1. to investigate if older age at the time of radical treatment has a negative impact on self-reported QoL, function and local adverse effects in prostate cancer survivors 2. to investigate if health status, health problems, and use of health care services in older prostate cancer survivors differ from a general male population of the same age Secondary aims are 1. to investigate how local adverse effects after radical prostate cancer treatment may influence QoL and functioning in both older and younger survivors, and to explore how other factors such as treatment modality and comorbidity may influence these outcomes 2. to investigate if health status, health problems, and use of health care services in younger prostate cancer survivors (being < 70 years by the time of treatment) differ from a general male population of the same age Study conduct All men who are eligible according to the inclusion criteria (see sample size below and inclusion criteria), will be invited to participate. All participants will provide written informed consent. In Study I, participants will be asked to fill in a questionnaire covering QoL (EORTC QLQ-C30 questionnaire), local adverse effects after prostate cancer treatment (the EPIC-26) and other health problems (selected items from the HUNT4 Survey). Participants in Study I, who were 70 years or more by the time they received their cancer treatment, will subsequently be asked to fill in an additional questionnaire covering a broader range of health issues also with items from the HUNT4 Survey (Study IIA). Questionnaires will be administered by post with pre-paid return envelopes attached. To fulfill our aims, we will investigate the association between age at treatment and QoL, self-reported health status, and local adverse effects (Primary aim 1). Furthermore, we will compare self-reported health, health problems, and use of health care services between our study population and the drawn control group (Primary aim 2 and Secondary aim 2). We will also investigate how local adverse effects may influence prostate cancer survivors' QoL and functioning (Secondary aim 1). Sample size and statistics About 1400 men with prostate cancer received curative treatment for local or localized prostate cancer at Innlandet Hospital Trust from 2014 to 2018, and about 1200 of these are estimated to be eligible for the initial study I. Matched controls will be drawn from the HUNT4 and HUNT4 70+ surveys, distribution 1:3 (cancer survivors : controls). Simple descriptive statistics will be used to describe our cohorts. Comparison between groups will be made using parametric and non-parametric statistics as appropriate. To assess the impact of age, treatment regimen and relevant confounding factors on outcomes, multiple regression models will be estimated. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04863352
Study type Observational
Source Sykehuset Innlandet HF
Contact Marit Slaaen, PhD
Phone 91857831
Email [email protected]
Status Not yet recruiting
Start date May 2021
Completion date December 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04081636 - Prostate Biopsy: Efficacy and Complications N/A
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Recruiting NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Active, not recruiting NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Active, not recruiting NCT00499421 - Evaluation of Intraprostatic Fiducial Markers For External Beam Radiation Therapy
Recruiting NCT03668652 - Focal Prostate Ablation Versus Radical Prostatectomy N/A
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Recruiting NCT04249154 - Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer Phase 2
Recruiting NCT03700099 - Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Treatment With Docetaxel Followed by Enzalutamide Phase 2
Recruiting NCT04219059 - MR Radiomic Features in Prostate Cancer
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT00953576 - Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer Phase 1/Phase 2
Recruiting NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1