Prostate Cancer
Conditions
Keywords
prostate cancer, older patients, immediate curative treatment, conservative treatment
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONRadiotherapy or surgery
see arm/ group description
OTHERinitial observation
see arm/ group description
DRUGHormone therapy
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Sponsors
Oslo University Hospital
Klinbeforsk
Sven Löffeler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, parallel, open-label
Eligibility
Sex/Gender
MALE
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participant must be 75 years of age or older, at the time of signing the informed consent. 2. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score \>14, or reversibly frail; miniCOGTM: score \>2) And who have PCa (diagnosed ≤6 months) with one or both of the following features: * Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5) * Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study) * Able to read, understand and fill in HRQoL questionnaires (PROMS) 3. Male 4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Medical Conditions 1. Dementia (unable to consent) Prior/Concomitant Therapy 2. Prior radiation to the pelvis 3. Hormone therapy \>3 months prior to randomization Diagnostic assessments 4. Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board). 5. Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board). Other Exclusions 6. Disabled or severe comorbidity (identified by G8 screening) 7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burden of disease | 0-10 years | 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) |
| Overall survival | 10 years following end of recruitment | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life-adjusted years | 0-10 years | Euro QoL group questionaire (EQ-5D-5L) (1 =full health; 0= dead) |
| need for secondary and tertiary therapy | 0-10 years | use of second- and third-line therapies |
| Metastasis-free survival | 0-10 years | time to metastasis detected radiographically due to symptoms or biochemical progression |
| Symptom-/ intervention-free survival | 0-10 years | time to symptoms/ need for interventions due to prostate cancer progression |
| bowel symptoms | 0-10 years | Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), bowel scales (score 0-100, higher scores indicating better outcomes) |
| Prostate cancer morbidity | 0-10 years | hospitalizations, interventions, complications due to local progression/ systemic progression) |
| Prostate-cancer-specific survival | 0-10 years | Prostate cancer deaths in intervention and control group |
| Role functioning | 0-10 years | 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) |
| Urinary irritative/ obstructive symptoms | 0-10 years | Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26),urinary scales (score 0-100, higher scores indicating better outcomes) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life in cancer patients | 0-10 years | 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) |
| Health-related quality of life in older cancer patients | 0-10 years | 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) |
| Quality of Life issues in patients with prostate cancer | 0-10 years | Expanded Prostate Cancer Index Composite Short Form questionnaire (EPIC-26), scales not secondary outcomes (score 0-100, higher scores indicating better outcomes) |
| Instrumental activities of daily living (iADL) | 0-10 years | Lawton and Brody questionnaire (8 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance) |
| Personal activities of daily living (pADL) | 0-10 years | Lawton and Brody questionnaire (6 questions, minimum score 0, maximum score 5, higher scores indicating need for assistance) |
| Institutionalized care | 0-10 years | 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. |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Primary ContactSven Loffeler, MD, PhD
Backup ContactErik S Haug, MD, PhD
Outcome results
None listed