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Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort

NCT07607431 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2026-05-26

No results posted yet for this study

Summary

The goal of this observational study is to examine the development and impact of lymphedema in men treated for prostate cancer. Lymphedema is swelling caused by damage to the lymphatic system and may develop after surgery with lymph node removal or after radiotherapy.

The main questions it aims to answer are:

How many men develop lower limb lymphedema after prostate cancer treatment? Which men are at highest risk of developing lymphedema? How does lymphedema affect quality of life?

Participants will attend follow-up visits every three months for 18 months at one of three Danish hospital sites: Rigshospitalet, Herlev-Gentofte Hospital, or Zealand University Hospital. At each visit, participants will undergo examinations for signs of lymphedema and complete questionnaires about symptoms, quality of life, and daily functioning. Participants who develop signs of lymphedema during the study will be advised to seek assessment and treatment from the hospital's lymphedema therapist.

Conditions

Interventions

OTHER

Radical Prostatectomy and Radiotherapy

Participants receive either radical prostatectomy with pelvic lymph node dissection or radiotherapy to the pelvic region as part of standard treatment for prostate cancer. Treatments are not assigned by the study.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Denmark

Study Locations

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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 NCT07607431 on ClinicalTrials.gov