Prostate CancerAWARENCT07607431
Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
An observational study of Prostate Cancer and Lower Limb Lymphedema, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Lower Limb Lymphedema
- What is being tested?
- Radical Prostatectomy and Radiotherapy
- How many people
- 214 participants
- Where
- 3 sitesDenmark
- Study dates
- 2 Feb 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- Men diagnosed with any stage prostate cancer
- Planned prostatectomy with lymph node removal or radiotherapy
- Able to understand Danish
Who cannot join
- History of lymph node dissection/radiotherapy at the level of the pelvic or groin
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Rigshospitalet
Copenhagen, 2100
Herlev and Gentofte Hospital
Herlev, 2730
Zealand University Hospital
Roskilde, 4000
About this study
Official title: 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:
Read more
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
- Being tested
- Radical Prostatectomy and Radiotherapy
- Keywords
- Prostate cancer, Lower Limb Lymphedema, Lymphedema, Health-related quality of life
- Medical subject headings
- Prostatic Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Prostatectomy and RadiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Radical Prostatectomy and Radiotherapy | Not described Receives: Other: Radical Prostatectomy and Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Lymphedema-related functioning, disability, and health will be assessed using the Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). Scores range from 0 to 100, with higher scores indicating greater impairments in function, activity limitations, and participation restrictions related to lower limb lymphedema.
Measured: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Quality of life measured by EORTC QLQ-C30
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0-100 scale. For global health status and functioning scales, higher scores indicate better health-related quality of life or functioning. For symptom scales/items, higher scores indicate greater symptom burden.
Measured: 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
Prostate cancer-specific symptoms and functioning, including urinary symptoms and sexual function, will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25). Scores are transformed to a 0-100 scale. For symptom scales/items, higher scores indicate greater symptom burden. For functioning scales, higher scores indicate better functioning.
Measured: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Physical activity measured by International Physical Activity Questionnaire (IPAQ)
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Physical activity will be reported as MET-minutes per week, with higher scores indicating higher levels of physical activity.
Measured: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start2 Feb 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bolette Rafn, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607431
- Sponsor's protocol ID
- AWARE
- Other IDs
- R352-A20774
- Acronym
- AWARE
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40518468Clinckaert 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.
PubMed 36428759
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Forgotten Sex in Lymphedema Research: Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
- ClinicalTrials.gov ID
- NCT07607431
- Acronym / sponsor ID
- AWARE / AWARE
- Conditions
- Prostate Cancer, Lower Limb Lymphedema
- Keywords
- Prostate cancer, Lower Limb Lymphedema, Lymphedema, Health-related quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical Prostatectomy and Radiotherapy | – | Other: Radical Prostatectomy and Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Men diagnosed with any stage prostate cancer
- Planned prostatectomy with lymph node removal or radiotherapy
- Able to understand Danish
Key exclusion criteria (1 listed)
- History of lymph node dissection/radiotherapy at the level of the pelvic or groin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical Prostatectomy and RadiotherapyParticipants 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. | Other | Radical Prostatectomy and Radiotherapy |
Primary outcome
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.
5 secondary outcomes
Depression using the Major Depression Inventory (MDI)
Time frame: 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 40518468Jensen 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.
- Background: PubMed 36428759Clinckaert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Lower Limb Lymphedema, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of lymphedema (time frame: From initiation of prostate cancer treatment through 18 months follow-up, assessed every 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607431, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.