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NCT07607431Active, not recruiting

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

Addressing the Forgotten Sex in Lymphedema Research: Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
214 (actual)
First submitted
19 May 2026
Start date
2 Feb 2024
Primary completion date
31 Oct 2026
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
NCT number
NCT07607431

What you commit to

  • Study type: Observational
  • Participants enrolled: 214
  • From 2 Feb 2024 to the primary completion date, 31 Oct 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of lymph node dissection/radiotherapy at the level of the pelvic or groin

Who the study is looking for

  • Age ≥18 years
  • Men diagnosed with any stage prostate cancer
  • Planned prostatectomy with lymph node removal or radiotherapy
  • Able to understand Danish

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status
Herlev and Gentofte Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkUnknown status
Zealand University Hospital
Coordinator of this site? Confirm its status
RoskildeDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.