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

NCT05448547 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Radiotherapy or surgery

see arm/ group description

OTHER

initial observation

see arm/ group description

DRUG

Hormone therapy

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Klinbeforsk

    collaborator OTHER

  • Sven Löffeler

    lead OTHER

Principal Investigators

  • Sven Loffeler, MD, PhD · The Hospital of Vestfold

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2029-12-31
Completion
2036-12-31

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05448547 on ClinicalTrials.gov