An observational study in Penile Cancer, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to male participants. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Oslo University Hospital · Observational
The proposed project is intended as a prospective study that includes 60 patients with newly diagnosed penile squamous cell carcinoma (SCC) referred to Oslo University Hospital (OUH), Radiumhospitalet, for surgery, primarily organ-sparing surgery (OSS).
OSS may improve not only quality of life, but also quality of sexual function. However, there is a potential for increased risk of local recurrence after OSS compared to the amputation of the penis. Appropriate preoperative staging, including multi-parametric magnetic resonance imaging (mpMRI), can substantially improve selection of patients and decrease the recurrence rate after surgery.
MpMRI without artificial erection is promising diagnostic tool that is poised to be all-in-one solution for staging and preoperative assessment of primary penile cancer, especially prior to OSS. The method is non-invasive and thus comfortable to perform for most of the patients. Novel MRI techniques are not incorporated into current clinical recommendations, and the potential of new, functional sequences has not been evaluated before. The accuracy of functional, non-erectile mpMRI for detecting and staging of primary penile cancer is not known. Thus, the main purpose of this study is to assess the diagnostic value of this method for preoperative assessment of penile cancer.
80 studies on the registry are indexed under Penile Neoplasms; 25 are open to participants now.
This study's planned enrollment of 60 is below the median of 167 across 13 observational studies indexed under Penile Neoplasms.
Browse Penile Neoplasms studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with newly diagnosed penile squamous cell carcinoma (SCC), referred to surgical treatment.
Exclusion Criteria:
Patients with penile squamous cell carcinoma.
Diagnostic Test: Multi-parametric, functional magnetic resonance imaging (MRI)
Multi-parametric, functional magnetic resonance imaging (MRI) will be performed in all included patients prior to surgery.
Functional imaging
Assess tumor extent and infiltration depth on multi-parametric MRI (mrT-stage) with histopathological evaluation as a reference standard. Explore usefulness of multi-parametric MRI in assessing inguinal and pelvic lymph nodes (mrN-stage). 2-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (FDG PET-CT), sentinel lymph node evaluation and histopathological examination of the resected specimen will be a gold standard.
Time frame: 2022-2024
Clinical outcome
Assess the locoregional recurrence rate and 5-year survival rate following OSS. Clinical outcome data will be obtained from 5 years clinical follow-up at the Department of Urology OUH.
Time frame: 2022-2030
Functional outcome
Evaluation of urinary and sexual function following surgery. Functional outcome data will be assessed by urologists using a scoring system and according to the clinical practice, and from interviews with clinical sexologist.
Time frame: 2022-2030
Plan to share: No
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Oslo University Hospital