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
- Diseases
- Prostate cancer
- 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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Herlev and Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Zealand University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.