Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lower Limb Lymphedema | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Prostatectomy and Radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radical Prostatectomy and Radiotherapy
- interventionNames
- Other: Radical Prostatectomy and Radiotherapy
Primary outcomes (1)
- measure
- Incidence of lymphedema
- timeFrame
- From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
- description
- Measured using multiple parameters, including bioimpedance spectroscopy, leg volume measurements, patient-reported symptoms, pitting, and clinical evaluation by a lymphedema therapist or physician.
Secondary outcomes (5)
- measure
- Depression using the Major Depression Inventory (MDI)
- timeFrame
- From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
- description
- Depressive symptoms will be assessed using the Major Depression Inventory (MDI). The MDI total score ranges from 0 to 50, with higher scores indicating more severe depressive symptoms.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDJensen S, Roder A, Hayes S, Larsen GS, Fode M, Ostergren PB, Al-Hamadani MMN, Johansen C, Rafn BS. Comprehensive assessment of lower limb edema and its association with quality of life among men with prostate cancer. Support Care Cancer. 2025 Jun 16;33(7):586. doi: 10.1007/s00520-025-09613-4. PMID 40518468
- BACKGROUNDClinckaert A, Callens K, Cooreman A, Bijnens A, Moris L, Van Calster C, Geraerts I, Joniau S, Everaerts W. The Prevalence of Lower Limb and Genital Lymphedema after Prostate Cancer Treatment: A Systematic Review. Cancers (Basel). 2022 Nov 18;14(22):5667. doi: 10.3390/cancers14225667. PMID 36428759