FDG-PET/CT alters treatment in node-positive penile cancer
| ISRCTN | ISRCTN49141161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49141161 |
- Submission date
- 23/05/2023
- Registration date
- 29/06/2023
- Last edited
- 01/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Screening for metastases (cancer that has spread) with a CT scan of the thorax and abdomen has a limited sensitivity (20-38%). The added value of investigating patients at risk for locoregional (localized region of the body) and distant spread, as well as screening for synchronous malignancies, is not known. However, for pelvis lymph nodes higher sensitivity has been reported for PET/CT in penile cancer. Findings also suggest that the fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) scan and sentinel node biopsy might have a complementary value. The aim of this study is to find out whether FDG-PET/CT has practical implications in the care of patients with advanced penile cancer and nodal metastases and alters treatment compared to ordinary staging with a CT scan.
Who can participate?
Patients aged 18 years and over with node-positive penile cancer in Sweden
What does the study involve?
Participants undergo FDG-PET/CT to investigate the proportion of patients subjected to altered treatment based on the FDG-PET/CT findings.
What are the possible benefits and risks of participating?
Based on additional information on the extent of the disease, treatment could be altered according to additional information gained by FDG-PET/CT. Risks include additional confirmatory studies and tissue samples that might be necessary in relation to the FDG-PET/CT findings, and consequently a prolonged time to treatment start.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
December 2019 to March 2029
Who is funding the study?
Skåne University Hospital (Sweden)
Who is the main contact?
Fredrik Liedberg, fredrik.liedberg@med.lu.se
Contact information
Principal Investigator
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-20502
Sweden
 ORCID ID |
0000-0001-8193-0370 |
|---|---|
| Phone | +46 (0)40 33 10 00 |
| fredrik.liedberg@med.lu.se |
Study information
| Study design | Prospective multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | NoDe-pOsitive penile cancer and FDG-PET/CT – does PET modify treatment? (DO PET) |
| Study acronym | DO PET |
| Study objectives | Fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) in patients with advanced penile cancer with nodal metastases alters treatment compared to ordinary staging with CT. |
| Ethics approval(s) | Approved 21/02/2020, Etikprövningsmyndigheten (Box 2110, SE750 02 Uppsala, Sweden; +46 (0)10 457 08 00; registrator@etikprovning.se), ref: Dnr 2019-04456 and 2020-02375 |
| Health condition(s) or problem(s) studied | Penile cancer |
| Intervention | The researchers prospectively apply FDG-PET/CT in all penile cancer patients with node-positive disease to investigate the proportion of patients subjected to altered treatment based on the FDG-PET/CT findings. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | FDG-PET/CT |
| Primary outcome measure | Altered treatment according to FDG-PET/CT findings, measured using FDG-PET/CT discussions at multidisciplinary team (MDT) prior to planning definitive treatment |
| Secondary outcome measures | Sensitivity for detection of iliac lymph node metastases, measured using FDG-PET/CT discussions at multidisciplinary team (MDT) prior to planning definitive treatment |
| Overall study start date | 31/12/2019 |
| Completion date | 01/03/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 100 |
| Key inclusion criteria | Node-positive penile cancer (cN+ or cN3 after sentinel node biopsy) |
| Key exclusion criteria | Age below 18 years |
| Date of first enrolment | 27/02/2020 |
| Date of final enrolment | 01/03/2029 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden
Södra Grev Rosengatan
Örebro
SE-701 85
Sweden
Sponsor information
Hospital/treatment centre
Department of Urology
Jan Waldenströms gata 5
Malmö
SE-205 02
Sweden
| Phone | +46 (0)40 33 10 00 |
|---|---|
| Jenny.Hellfalk@skane.se | |
| Website | http://www.skane.se/sv/Webbplatser/Skanes-universitetssjukhus/ |
"ROR" |
https://ror.org/02z31g829 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Skåne University Hospital, SUS
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/03/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed medical journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available |
Editorial Notes
01/08/2025: The contact confirmed the record is up to date.
25/05/2023: Study's existence confirmed by the Etikprövningsmyndigheten.
