Health Trials

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age75+
SponsorSven Löffeler

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant must be 75 years of age or older, at the time of signing the informed consent.

Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score >14, or reversibly frail; miniCOGTM: score >2)

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)

Disqualifiers

Dementia (unable to consent) Prior/Concomitant Therapy

Prior radiation to the pelvis

Hormone therapy >3 months prior to randomization Diagnostic assessments

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy or surgery

    Radiation

    see arm/ group description

  • initial observation

    Other intervention

    see arm/ group description

  • Hormone therapy

    Drug

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

Treatment groups

980 Participants
are divided into 2 treatment groups
Group A: immediate curative therapyExperimental treatment 1 intervention
Group B: initial observation/ hormone therapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

overall survival

Time frame
10 years following end of recruitment
2

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

Secondary outcomes

1

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
2

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
3

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
4

Prostate cancer morbidity

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

Time frame
0-10 years

Other outcomes

1

Institutionalized care

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.

Time frame
0-10 years
2

Health-related quality of life in cancer patients

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)

Time frame
0-10 years
3

Health-related quality of life in older cancer patients

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)

Time frame
0-10 years
4

Quality of Life issues in patients with prostate cancer

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

Time frame
0-10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sven Löffeler

Lead sponsor

The Hospital of Vestfold

Sponsor institution

Oslo University Hospital

Collaborator

Klinbeforsk

Collaborator

Source ClinicalTrials.gov
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