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

NCT07607431 | Active Not Recruiting

• 2 other identifiers: AWARER352-A20774
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 3

Brief 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

Prostate Cancer; Lower Limb Lymphedema

Keywords

Prostate cancer; Lower Limb Lymphedema; Lymphedema; Health-related quality of life

Outcome Measures

Primary Outcomes (1)

• Incidence of lymphedema

  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 Outcomes (5)

• Depression using the Major Depression Inventory (MDI)

  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

  From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.

• Quality of life measured by EORTC QLQ-C30

  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

  From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.

• Physical activity measured by International Physical Activity Questionnaire (IPAQ)

  From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.

Study Arms (1)

Radical Prostatectomy and Radiotherapy

Other: Radical Prostatectomy and Radiotherapy

Interventions

Radical Prostatectomy and Radiotherapy OTHER

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.

Radical Prostatectomy and Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Related Publications (2)

• Jensen 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 BACKGROUND

• Clinckaert 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Lymphedema

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: February 2, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

DK (3)