It is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (\>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
There is a lack of both level 1 evidence and consensus regarding the optimal treatment strategy for older men (\>=75 years) with non-metastatic, high-risk prostate cancer. Currently, in Scandinavia, the majority of older patients are treated conservatively, i.e. with hormone therapy or watchful waiting while some centers recommend immediate curative therapy regardless of patient age. Older patients thus risk both undertreatment and overtreatment of their cancer. This randomized clinical trial investigates if immediate curative therapy of high-risk, non-metastatic prostate cancer prolongs life (as it does in younger patients) and improves health-related quality of life. Furthermore, this trial investigates if the early side effects of immediate curative therapy are compensated by better long-term tumor control, better quality of life, functional status and improved survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
980
see arm/ group description
see arm/ group description
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Rigshospital
Copenhagen, Denmark
RECRUITINGEsbjerg and Grindsted Hospital
Esbjerg, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGHelsinki University Hospital
Helsinki, Finland
RECRUITINGTampere University Hospital
Tampere, Finland
RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGSunmøre Hospital Trust
Ålesund, Møre og Romsdal, Norway
RECRUITINGOslo University Hospital
Oslo, Oslo County, Norway
RECRUITINGStavanger University Hospital
Stavanger, Rogaland, Norway
RECRUITINGSørlandet Hospital Trust
Kristiansand, Sørlandet, Norway
RECRUITING...and 8 more locations
Overall survival
overall survival
Time frame: 10 years following end of recruitment
Burden of disease
European Organisation for Research and Treatment of Cancer questionnaire for assessment of health-related quality of life elderly patients with cancer (EORTC ELD 14), burden of disease scale (2 questions, score 0-100, high scores indicate high burden of disease)
Time frame: 0-10 years
Role functioning
European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), RF2 scale (2 questions, score 0-100, high scores indicate a high / healthy level of functioning)
Time frame: 0-10 years
Urinary irritative/ obstructive symptoms
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes)
Time frame: 0-10 years
bowel symptoms
Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes)
Time frame: 0-10 years
Prostate cancer morbidity
hospitalizations, interventions, complications due to local progression/ systemic progression)
Time frame: 0-10 years
Prostate-cancer-specific survival
Prostate cancer deaths in intervention and control group
Time frame: 0-10 years
Metastasis-free survival
time to metastasis detected radiographically due to symptoms or biochemical progression
Time frame: 0-10 years
Symptom-/ intervention-free survival
time to symptoms/ need for interventions due to prostate cancer progression
Time frame: 0-10 years
Quality of life-adjusted years
Euro QoL group questionaire (EQ-5D-5L) (1 =full health; 0= dead)
Time frame: 0-10 years
need for secondary and tertiary therapy
use of second- and third-line therapies
Time frame: 0-10 years
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