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

May 19, 2026 updated by: Bolette Rafn, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Herlev, Denmark, 2730
        • Herlev and Gentofte Hospital
      • Roskilde, Denmark, 4000
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men with prostate cancer receiving radical prostatectomy with pelvic lymph node dissection or radiotherapy at three urological departments in Eastern Denmark: Rigshospitalet, Herlev-Gentofte Hospital, and Zealand University Hospital.

Description

Inclusion criteria

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

Exclusion criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radical Prostatectomy and Radiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of lymphedema
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Measured using multiple parameters, including bioimpedance spectroscopy, leg volume measurements, patient-reported symptoms, pitting, and clinical evaluation by a lymphedema therapist or physician.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression using the Major Depression Inventory (MDI)
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Functioning, Disability and Health associated with lymphedema measured by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Quality of life measured by EORTC QLQ-C30
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Urinary dysfunction and sexual function measured with the prostate cancer-specific subscale EORTC QLQ-PR25
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Physical activity measured by International Physical Activity Questionnaire (IPAQ)
Time Frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWARE
  • R352-A20774 (Other Grant/Funding Number: Danish cancer society)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Radical Prostatectomy and Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe