Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

All Drugs and Chemicals

Androgens

Hormones

Hormone Antagonists

Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.

Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.

Radiotherapy or surgery

initial observation

androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy

Hormone therapy

Sven Loffeler, MD, PhD

Erik S Haug, MD, PhD

Klaus Brasso, Prof, PhD

Mads H Poulsen, MD, PhD

Teemu Murtola, Prof, PhD

Bjørg Aksnessæther

Maria Nyre Vigmostad, MD

Christoph Müller, MD, PhD

Torgrim M Tandstad, MD, PhD, Professor

Sven Löffeler

Erik S Haug

Ola Christiansen, MD

Kirsti Aas, MD, PhD

Kristian Thon, MD, PhD

Anne Marie Holck Storås, MD, PhD

Hege S Haugnes, Prof, PhD

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.

Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer

A Randomized, Open-label, Multicenter, Parallel Group Treatment, Phase 3, Two-arm Study to Measure the Effect on Overall Survival and Quality of Life of Immediate Curative Therapy Compared With Standard Conservative Treatment in Older Male Participants Aged ≥ 75 Years With Non-metastatic, High-risk Prostate Cancer

at each follow-up visit the living status of the patients will be assessed. If patients have become dependent on permanent nursing home/ assisted care this will be registered.

European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), scales not primary/ secondary outcome measures (All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems)

European Organisation for Research and Treatment of Cancer questionnaire for quality of life of cancer patients (EORTC-QLQ-C30), scales not primary outcome (All of the scales and single-item measures range in score from 0 to 100. High scores indicate poor mobility, good family support, much worry about the future, good maintenance of autonomy and purpose)

Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), scales not secondary outcomes (score 0-100, higher scores indicating better outcomes)

Lawton and Brody questionnaire (8 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance)

Lawton and Brody questionnaire (6 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance)

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)

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)

Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes)

Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes)

hospitalizations, interventions, complications due to local progression/ systemic progression)

Prostate cancer deaths in intervention and control group

time to metastasis detected radiographically due to symptoms or biochemical progression

Spots Global Cancer Trial Database for immediate curative treatment